Trial Outcomes & Findings for Ellipsys Vascular Access System Post Market Surveillance (PS) Study (NCT NCT04484220)
NCT ID: NCT04484220
Last Updated: 2026-05-07
Results Overview
Freedom from access abandonment from time of access creation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
12 months post-procedure
Results posted on
2026-05-07
Participant Flow
142 subjects signed Informed Consent and make up the "started" group. 11 subjects did not have or did not attempt to have the study device deployed. This is how the Safety population of 131 subjects value was calculated (142-11=131).
Participant milestones
| Measure |
Ellipsys Vascular Access System
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
|
Overall Study
STARTED
|
142
|
|
Overall Study
Safety Population
|
131
|
|
Overall Study
COMPLETED
|
98
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Ellipsys Vascular Access System
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
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|---|---|
|
Overall Study
Kidney transplant
|
2
|
|
Overall Study
Peritoneal Dialysis
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
7
|
|
Overall Study
Physician Decision
|
11
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
No procedure initiated, withdrawn prior to procedure
|
6
|
|
Overall Study
Unsuccessful Procedure, device not attempted to be used
|
5
|
Baseline Characteristics
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
Baseline characteristics by cohort
| Measure |
Ellipsys Vascular Access System
n=131 Participants
The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients who have chronic kidney disease requiring dialysis.
Ellipsys Vascular Access System: The Ellipsys System is indicated for the creation of a proximal radial artery to perforating vein anastomosis via a retrograde venous access approach in patients with a minimum vessel diameter of 2.0mm and less than 1.5mm of separation between the artery and vein at the fistula creation site who have chronic kidney disease requiring dialysis.
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|---|---|
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Age, Continuous
|
60.1 years
STANDARD_DEVIATION 14.1 • n=54 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=54 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=54 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=54 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=54 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=54 Participants
|
|
Region of Enrollment
United States
|
131 Participants
n=54 Participants
|
|
Body Mass Index (BMI)
|
29.3 kg/m2
STANDARD_DEVIATION 6.9 • n=54 Participants
|
PRIMARY outcome
Timeframe: 12 months post-procedurePopulation: Cumulative patency is defined as freedom from access abandonment from time of access creation. Abandoned dialysis access is one that can no longer be used for 1 or 2- needle dialysis, it is unable to provide adequate blood flow and/or is unsafe for the patient, and the problem cannot be corrected by any intervention either medical, endovascular, or surgical. Cumulative patency is summarized for the treated pop. was reported by using the Kaplan-Meier survival estimate at 12 months, as a %.
Freedom from access abandonment from time of access creation
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
|
Cumulative Patency Through 12 Months Post-AVF Creation
|
99.1 Probability as a percentage
Interval 97.4 to 100.0
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PRIMARY outcome
Timeframe: 7 days post-procedurePopulation: The primary safety endpoint of the Ellipsys PS study is early occlusion, defined as the percentage of subjects with a total occlusion within seven (7) days of the AVF creation procedure.
Percent of patients with total occlusion within 7 days of the AVF creation procedure
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
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|---|---|
|
Early Occlusion Rate at 7 Days
|
1.5 Percentage of Subjects
Interval 0.4 to 6.3
|
PRIMARY outcome
Timeframe: 12 months post-procedurePopulation: Numbers are % (number of subjects with at least one event/number of subjects in the safety population) unless otherwise stated.
This event rate is reported as the percentage of participants with at least one Serious Adverse Event through 12 Months, related to the device, study procedure, or secondary procedure to maintain or re-establish patency.
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
|
Study Related Serious Adverse Event (SAE) Rate Through 12 Months
Procedure or Device related Serious Adverse Events Post-market events with 97.5% CI
|
12.2 percentage of participants
Interval 7.2 to 20.1
|
|
Study Related Serious Adverse Event (SAE) Rate Through 12 Months
UADE Post-market events with 97.5% CI
|
0 percentage of participants
Interval 0.0 to 3.7
|
|
Study Related Serious Adverse Event (SAE) Rate Through 12 Months
Procedure related Post-market events with 97.5% CI
|
13.7 percentage of participants
Interval 8.3 to 21.8
|
SECONDARY outcome
Timeframe: 12 months post-procedurePopulation: Primary patency is defined as freedom from access thrombosis, or any intervention designed to facilitate, maintain or re-establish patency in a thrombosed access from time of access creation. Primary patency is summarized for the treated population using a Kaplan-Meier survival probability curve through at least 12 months, expressed as a percentage.
Freedom from access thrombosis or any intervention designed to facilitate, maintain or re-establish patency measured from time of access creation through 12 months
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
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|---|---|
|
Primary Patency Through 12 Months Post-AVF Creation
|
54.1 Probability as a percentage
Interval 45.9 to 63.9
|
SECONDARY outcome
Timeframe: 12 months post-procedurePopulation: Assisted primary patency is defined as freedom from access thrombosis from time of access creation Through 12 months Post-AVF Creation. Assisted primary patency is summarized for the treated population was reported by using the Kaplan-Meier survival estimate at 12 months, expressed as a percentage.
Freedom from access thrombosis from time of access creation through 12 months post-AVF creation
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
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|---|---|
|
Assisted Primary Patency Through 12 Months Post-AVF Creation
|
90.1 Probability as a percentage
Interval 85.0 to 95.6
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SECONDARY outcome
Timeframe: 12 months post-procedurePopulation: Secondary procedures are surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow. Secondary procedures are procedures subsequent to completion of the AVF creation procedure. Rate based measurement; the rate corresponds to the count of secondary procedures over the total person-years of follow-up.
Secondary procedure rate will be summarized cumulatively through 12 months as the number of procedures per person-years as well as the number and percentage of subjects having one or more procedures in the Treated population (see 8. Secondary Outcome Measure).
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
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Secondary Procedures Rate, Per Person Years
|
2.02 procedures per person-years
|
SECONDARY outcome
Timeframe: 12 months post-procedurePopulation: Summary of Participants Experiencing Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
A full characterization of adverse events during the study
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Device Related Adverse Events
|
6.1 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Procedure Related Adverse Events
|
13.7 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Intra-Procedure Related Adverse Events
|
6.1 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Secondary Procedure Related Adverse Events
|
8.4 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
4-week Maturation Related Adverse Events
|
2.3 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Cannulation Related Adverse Event
|
7.6 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Total Adverse Events
|
47.3 percentage of subjects reporting event
|
|
Overall Patient Safety-Serious, Device-Related, Procedure-Related, Secondary Procedure-Related and/or Cannulation-Related Adverse Events
Serious Adverse Events
|
42 percentage of subjects reporting event
|
SECONDARY outcome
Timeframe: 12 months post-procedurePopulation: Secondary procedures are surgical or percutaneous interventions designed to mature or maintain the AVF or re-establish flow. Secondary procedures are procedures subsequent to completion of the AVF creation procedure. Rate based measurement; the rate corresponds to the count of secondary procedures over the total person-years of follow-up.
Secondary procedure rate will be summarized cumulatively through 12 months as the number of procedures per person-years as well as the number and percentage of subjects having one or more procedures in the Treated population. (see 6. Secondary Outcome Measure)
Outcome measures
| Measure |
Ellipsys Vascular Access System
n=131 Participants
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
|
Secondary Procedures Rate, Percentage of Subjects
Subjects with zero (0) secondary procedures
|
20 Participants
|
|
Secondary Procedures Rate, Percentage of Subjects
Subjects with one (1) secondary procedures
|
37 Participants
|
|
Secondary Procedures Rate, Percentage of Subjects
Subjects with two (2) secondary procedures
|
42 Participants
|
|
Secondary Procedures Rate, Percentage of Subjects
Subjects with three (3) secondary procedures
|
12 Participants
|
|
Secondary Procedures Rate, Percentage of Subjects
Subjects with four (4 +) or more secondary procedures
|
20 Participants
|
Adverse Events
Ellipsys Vascular Access System
Serious events: 55 serious events
Other events: 3 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Ellipsys Vascular Access System
n=131 participants at risk
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
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|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
3/131 • Number of events 5 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Arrhythmia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Atrial Fibrillation
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Atrial Flutter
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Bradycardia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Cardiac Arrest
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Myocardial Infarction
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Gastrointestinal disorders
Gastritis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.76%
1/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Gastrointestinal disorders
Nausea
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
General disorders
Chest Pain
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
General disorders
Oedema Peripheral
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
General disorders
Pyrexia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Hepatobiliary disorders
Cryptogenic Cirrhosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Bacteraemia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Intervertebral Discitis
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Osteomyelitis
|
1.5%
2/131 • Number of events 4 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Pneumonia
|
3.1%
4/131 • Number of events 4 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Pseudomonal Bacteraemia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Infections and infestations
Vascular Device Infection
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Anastomotic Stenosis
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Occlusion
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
3.8%
5/131 • Number of events 5 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haematoma
|
1.5%
2/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Device Difficult To Use
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Dialysis Disequilibrium Syndrome
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Vascular Access Site Extravasation
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Venous Injury
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Nervous system disorders
Holmes Tremor
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Nervous system disorders
Metabolic Encephalopathy
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Product Issues
Device Dislocation
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.76%
1/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Surgical and medical procedures
Aortic Aneurysm Repair
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Accelerated Hypertension
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Aortic Stenosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Arterial Spasm
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Hypertension
|
0.76%
1/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Hypertensive Emergency
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Hypertensive Urgency
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Hypotension
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Peripheral Artery Occlusion
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Peripheral Vein Occlusion
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Peripheral Vein Stenosis
|
4.6%
6/131 • Number of events 6 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Steal Syndrome
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Vascular Stenosis
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Vasospasm
|
1.5%
2/131 • Number of events 2 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Venous Hypertension
|
0.76%
1/131 • Number of events 1 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Vascular disorders
Venous Thrombosis Limb
|
3.1%
4/131 • Number of events 4 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
Other adverse events
| Measure |
Ellipsys Vascular Access System
n=131 participants at risk
Per the Ellipsys PS CIP, subjects are enrolled in the study when they complete the informed consent process. These subjects make up the 'enrolled subjects' population.
The 'safety population' per the CIP is defined as all enrolled subjects in whom the index procedure has been attempted and the Ellipsys Device deployed, whether successful or not.
|
|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
2.3%
3/131 • Number of events 3 • through 12 months
(SAE) per ISO 14155:2020, any of the following a) death, b) serious deterioration in the health of the subject, one or more of the following: 1) a life-threatening , or 2) a permanent impairment , or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) fetal distress
|
Additional Information
Heather Catchpole, Clinical Study Manager
Medtronic Vascular, Inc.
Phone: 707-560-3395
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER