Trial Outcomes & Findings for VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow Obstruction (NCT NCT02112877)

NCT ID: NCT02112877

Last Updated: 2021-04-15

Results Overview

The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-04-15

Participant Flow

A total of 200 subjects have been enrolled in the VIRTUS Trial, including 30 subjects in the feasibility cohort and 170 subjects in the pivotal cohort.

Participant milestones

Measure	VICI Stent Implantation - Feasibility Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Overall Study STARTED	30	170
Overall Study COMPLETED	28	157
Overall Study NOT COMPLETED	2	13

Reasons for withdrawal

Measure	VICI Stent Implantation - Feasibility Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Overall Study Withdrawal by Subject	1	7
Overall Study Visit Missed	1	6

Baseline Characteristics

For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.

Baseline characteristics by cohort

Measure	VICI Stent Implantation - Feasibility n=30 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=170 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	Total n=200 Participants Total of all reporting groups
Age, Continuous	44.4 years STANDARD_DEVIATION 14.3 • n=30 Participants	54.4 years STANDARD_DEVIATION 16.2 • n=170 Participants	52.9 years STANDARD_DEVIATION 16.3 • n=200 Participants
Sex: Female, Male Female	24 Participants n=30 Participants	96 Participants n=170 Participants	120 Participants n=200 Participants
Sex: Female, Male Male	6 Participants n=30 Participants	74 Participants n=170 Participants	80 Participants n=200 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=30 Participants	1 Participants n=170 Participants	1 Participants n=200 Participants
Race/Ethnicity, Customized Asian	2 Participants n=30 Participants	5 Participants n=170 Participants	7 Participants n=200 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=30 Participants	20 Participants n=170 Participants	21 Participants n=200 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=30 Participants	1 Participants n=170 Participants	1 Participants n=200 Participants
Race/Ethnicity, Customized White	25 Participants n=30 Participants	127 Participants n=170 Participants	152 Participants n=200 Participants
Race/Ethnicity, Customized White African	0 Participants n=30 Participants	1 Participants n=170 Participants	1 Participants n=200 Participants
Race/Ethnicity, Customized Latin American	0 Participants n=30 Participants	1 Participants n=170 Participants	1 Participants n=200 Participants
Race/Ethnicity, Customized Not Answered	0 Participants n=30 Participants	14 Participants n=170 Participants	14 Participants n=200 Participants
Race/Ethnicity, Customized North African	2 Participants n=30 Participants	0 Participants n=170 Participants	2 Participants n=200 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=27 Participants • For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.	13 Participants n=154 Participants • For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.	15 Participants n=181 Participants • For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.
Race/Ethnicity, Customized Not Hispanic or Latino	25 Participants n=27 Participants • For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.	141 Participants n=154 Participants • For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.	166 Participants n=181 Participants • For the feasibility cohort, ethnicity data has been provided by 27/30 subjects. For the pivotal cohort, 16 subjects from the sites located in France did not provide their ethnicity per the policy at each site.
Region of Enrollment Netherlands	1 Participants n=30 Participants	0 Participants n=170 Participants	1 Participants n=200 Participants
Region of Enrollment United States	8 Participants n=30 Participants	119 Participants n=170 Participants	127 Participants n=200 Participants
Region of Enrollment Ireland	3 Participants n=30 Participants	5 Participants n=170 Participants	8 Participants n=200 Participants
Region of Enrollment United Kingdom	10 Participants n=30 Participants	22 Participants n=170 Participants	32 Participants n=200 Participants
Region of Enrollment France	3 Participants n=30 Participants	18 Participants n=170 Participants	21 Participants n=200 Participants
Region of Enrollment Germany	0 Participants n=30 Participants	5 Participants n=170 Participants	5 Participants n=200 Participants
Region of Enrollment Spain	5 Participants n=30 Participants	1 Participants n=170 Participants	6 Participants n=200 Participants
Chronic Non-Malignant Obstruction Left Leg	24 Participants n=30 Participants	145 Participants n=170 Participants	169 Participants n=200 Participants
Chronic Non-Malignant Obstruction Right Leg	5 Participants n=30 Participants	24 Participants n=170 Participants	29 Participants n=200 Participants
Chronic Non-Malignant Obstruction Both Legs	1 Participants n=30 Participants	1 Participants n=170 Participants	2 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 0 (No visible or palpable signs of venous disease	1 Participants n=30 Participants	2 Participants n=170 Participants	3 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 1 (Telangiectasia or reticular veins)	0 Participants n=30 Participants	0 Participants n=170 Participants	0 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 2 (Varicose Veins)	0 Participants n=30 Participants	2 Participants n=170 Participants	2 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 3 (Edema)	13 Participants n=30 Participants	45 Participants n=170 Participants	58 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 4 (Skin changes ascribed to venous disease)	13 Participants n=30 Participants	78 Participants n=170 Participants	91 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 5 (Healed ulceration)	2 Participants n=30 Participants	22 Participants n=170 Participants	24 Participants n=200 Participants
Clinical Etiology Anatomy Pathophysiology (CEAP) Assessment 6 (Active ulceration)	1 Participants n=30 Participants	21 Participants n=170 Participants	22 Participants n=200 Participants
Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb) Absent	2 Participants n=30 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	15 Participants n=146 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	17 Participants n=176 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.
Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb) Mild	2 Participants n=30 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	35 Participants n=146 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	37 Participants n=176 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.
Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb) Moderate	17 Participants n=30 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	54 Participants n=146 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	71 Participants n=176 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.
Venous Clinical Severity Score (VCSS) Leg Pain (Target Limb) Severe	9 Participants n=30 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	42 Participants n=146 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.	51 Participants n=176 Participants • For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues.
Diabetic	2 Participants n=30 Participants	29 Participants n=170 Participants	31 Participants n=200 Participants
Smoking History Current Smoker	3 Participants n=30 Participants	21 Participants n=170 Participants	24 Participants n=200 Participants
Smoking History Former Smoker	8 Participants n=30 Participants	41 Participants n=170 Participants	49 Participants n=200 Participants
Smoking History Non-Smoker	19 Participants n=30 Participants	108 Participants n=170 Participants	127 Participants n=200 Participants
History of Pulmonary Embolism (PE)	2 Participants n=19 Participants • For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.	28 Participants n=130 Participants • For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.	30 Participants n=149 Participants • For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.
History of Deep Vein Thrombosis (DVT)	19 Participants n=19 Participants • For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.	119 Participants n=130 Participants • For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.	138 Participants n=149 Participants • For the feasibility cohort, only 19 subjects were initially classified as having a history of thromboembolic disease. For the pivotal cohort, only 130 subjects were initially classified as having a history of thromboembolic disease.
History of Coronary Artery Disease (CAD)	0 Participants n=30 Participants	14 Participants n=170 Participants	14 Participants n=200 Participants
History of Myocardial Infarction (MI) within past 5 years	0 Participants n=30 Participants	1 Participants n=170 Participants	1 Participants n=200 Participants
History of Coronary Artery Bypass Grafting (CABG)	0 Participants n=30 Participants	4 Participants n=170 Participants	4 Participants n=200 Participants
History of Percutaneous Transluminal Coronary Angioplasty (PTCA)/Stent	0 Participants n=30 Participants	4 Participants n=170 Participants	4 Participants n=200 Participants
History of Congestive Heart Failure (CHF)	0 Participants n=30 Participants	4 Participants n=170 Participants	4 Participants n=200 Participants
History of Hypertension (HTN)	7 Participants n=30 Participants	68 Participants n=170 Participants	75 Participants n=200 Participants
History of Hepatic Disease	1 Participants n=30 Participants	5 Participants n=170 Participants	6 Participants n=200 Participants
History of Renal Disease	1 Participants n=30 Participants	8 Participants n=170 Participants	9 Participants n=200 Participants
History of Peripheral Vascular Disease (PVD)	2 Participants n=30 Participants	29 Participants n=170 Participants	31 Participants n=200 Participants
History of Coagulation Disorder	7 Participants n=30 Participants	23 Participants n=170 Participants	30 Participants n=200 Participants
History of Cerebrovascular Accident (CVA)	1 Participants n=30 Participants	10 Participants n=170 Participants	11 Participants n=200 Participants
History of Cancer	2 Participants n=30 Participants	18 Participants n=170 Participants	20 Participants n=200 Participants
History of Recent Trauma	1 Participants n=30 Participants	3 Participants n=170 Participants	4 Participants n=200 Participants
History of Allergies	4 Participants n=30 Participants	60 Participants n=170 Participants	64 Participants n=200 Participants

PRIMARY outcome

Timeframe: 30 days

Population: For the pivotal cohort, one subject never returned for follow-up after discharge.

The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=30 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=169 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Major Adverse Events (MAE) Device or procedure-related arterial/venous injury	2 Participants	2 Participants
Number of Participants With Major Adverse Events (MAE) Device or procedure-related death	0 Participants	0 Participants
Number of Participants With Major Adverse Events (MAE) Device or procedure-related bleeding	0 Participants	0 Participants
Number of Participants With Major Adverse Events (MAE) Device or procedure-related acuteDeepVeinThrombus	0 Participants	0 Participants
Number of Participants With Major Adverse Events (MAE) Clinically significant pulmonary embolism	0 Participants	0 Participants
Number of Participants With Major Adverse Events (MAE) Embolization of the stent	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 12 months post-intervention

Population: For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, month 12 outcomes were available for 125 subjects. Those without venography performed at 12 months had their result assigned by random selection from subjects with a venogram result who had the same anatomy and the same DUS outcome (if available).

The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram.

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=22 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=170 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Percentage of Participants That Demonstrated Primary Patency	77.3 Percentage of Participants	84.0 Percentage of Participants

SECONDARY outcome

Timeframe: 12 months post-intervention

Population: For the feasibility cohort, 7 subjects did not have VCSS results at both month 12 and baseline. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues and 14 subjects did not have VCSS results at both month 12 and Baseline.

The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=23 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=132 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)	13 Participants	65 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During Procedure

Population: For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment. Additionally, there were two subjects that failed the endpoint due to two investigators using non-study stents.

Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed.

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=30 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=166 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Procedural Technical Success	30 Participants	164 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During Procedure

Population: For the pivotal cohort, four subjects did not have the post-procedural veogram available for assessment.

Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices).

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=30 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=166 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Lesion Success	30 Participants	166 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first)

Population: For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment.

Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=30 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=166 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Procedural Success	28 Participants	162 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-intervention

Population: For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, only 127 subjects had a 12-month venogram and/or stent fracture assessment.

Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures .

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=22 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=127 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Late Technical Success	16 Participants	97 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 12 months post-intervention

Population: For the feasibility cohort, three subjects did not have Month 12 CIVIQ-2 results. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues. Also, 11 subjects did not have a Month 12 visit and 2 subjects did not complete the CIVIQ forms.

The overall change in CIVIQ2 scores for the study patients, calculated using the mean scores at baseline and 12-months. This instrument is scored from 20 to 100 points with lower scores indicating a lesser impact on health.

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=27 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=133 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2))	-15.4 units on a scale Interval -22.1 to -8.6	-13.1 units on a scale Interval -16.3 to -10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post-intervention

Population: For the feasibility cohort, only 21 subjects had known outcomes. For the pivotal cohort, only 126 subjects had known outcomes.

Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=21 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=126 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Estimated Primary-Assisted Patency	20 Participants	117 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 36 months post-intervention

Population: For the feasibility cohort, 13 subjects had known outcomes. For the pivotal cohort, 97 subjects had known outcomes.

Secondary patency is defined as freedom from "permanent" loss of patency determined through last follow-up (irrespective of the number of interventions).

Outcome measures

Measure	VICI Stent Implantation - Feasibility n=13 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=97 Participants Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Number of Participants With Estimated Secondary Patency	13 Participants	93 Participants

Adverse Events

VICI Stent Implantation - Feasibility

Serious events: 14 serious events

Other events: 14 other events

Deaths: 0 deaths

VICI Stent Implantation - Pivotal

Serious events: 86 serious events

Other events: 102 other events

Deaths: 4 deaths

Serious adverse events

Measure	VICI Stent Implantation - Feasibility n=30 participants at risk Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=170 participants at risk Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Nervous system disorders Cerebral haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Internal hernia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Gastric perforation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Ileus	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Melaena	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent thrombosis	13.3% 4/30 • Number of events 6 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	5.9% 10/170 • Number of events 14 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent restenosis	6.7% 2/30 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	4.7% 8/170 • Number of events 9 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent stenosis	6.7% 2/30 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.4% 4/170 • Number of events 5 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent occlusion	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Stenosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Hepatobiliary disorders Cholelithiasis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Oedema peripheral	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Peripheral swelling	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular access site hemorrhage	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular access site hematoma	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular pseudoaneurysm ruptured	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Wound	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Delayed haemolytic transfusion reaction	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations International normalized ratio decreased	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Blood culture positive	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Haemoglobin decreased	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Specific gravity urine abnormal	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Renal vein compression	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Chronic kidney disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Acute kidney injury	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Asthma	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Venous angioplasty	13.3% 4/30 • Number of events 7 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	5.3% 9/170 • Number of events 11 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Venous stent insertion	10.0% 3/30 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Hysterectomy	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Thrombolysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.4% 4/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Vascular stent insertion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Angioplasty	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Thrombectomy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Varicose vein operation	6.7% 2/30 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.4% 4/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Hip arthroplasty	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Myomectomy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Hernia repair	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Transfusion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Interventional procedure	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Arteriovenous fistula	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Varicose vein	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Aneurysm ruptured	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Deep vein thrombosis	6.7% 2/30 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	10.0% 17/170 • Number of events 24 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Vena cava thrombosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Venous stenosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Venous occlusion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Aortic aneurysm	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Varicose ulceration	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Vascular compression	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Peripheral venous disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Phlebitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Product Issues Stent malfunction	6.7% 2/30 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Product Issues Device malfunction	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Product Issues Device dislocation	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.9% 5/170 • Number of events 5 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 5 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Sciatica	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Seizure	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Cerebrovascular accident	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Encephalopathy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Encephalomalacia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Psychiatric disorders Mental status changes	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders Sickle cell anaemia with crisis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Acute myocardial infarction	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Bradycardia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Cardiac failure congestive	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Pericardial effusion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Ventricular tachycardia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Atrial fibrillation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Sepsis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	3.5% 6/170 • Number of events 15 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Urinary tract infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.4% 4/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Cellulitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	4.7% 8/170 • Number of events 11 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Parotitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Cholecystectomy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Paget-Schroetter syndrome	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Puncture site haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Venous thrombosis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Product Issues Device occlusion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Intermittent claudication	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Pneumonia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Abdominal pain	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Catheterisation venous	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Pelvic venous thrombosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Haematoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Hypertensive crisis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Peripheral artery occlusion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Post thrombotic syndrome	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Vasculitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Abdominal wall abscess	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Arthritis bacterial	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Arthritis infective	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Erysipelas	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Oral candidiasis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Osteomyelitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Pneumonia bacterial	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Urosepsis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Atherectomy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Colostomy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Coronary arterial stent insertion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Knee arthroplasty	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Neurolysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Peripheral artery angioplasty	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Acute coronary syndrome	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Angina pectoris	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Right ventricular failure	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Sinus node dysfunction	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Rectal prolapse	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Anal prolapse	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Dysphagia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Intestinal prolapse	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Umbilical hernia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Dizziness	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Nerve root compression	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Syncope	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Thecal sac compression	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Haematocrit decreased	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Reproductive system and breast disorders Pelvic congestion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Immune system disorders Allergy to plants	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.

Other adverse events

Measure	VICI Stent Implantation - Feasibility n=30 participants at risk Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System	VICI Stent Implantation - Pivotal n=170 participants at risk Percutaneous stent placement in the common femoral vein, external iliac vein and/or common iliac vein Veniti Vici™ Venous Stent System
Blood and lymphatic system disorders Antiphospholipid syndrome	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Bradycardia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Palpitations	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Cardiac disorders Cyanosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Eye disorders Vision blurred	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Eye disorders Blindness	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Abdominal distension	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.4% 4/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.9% 5/170 • Number of events 5 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Vomiting	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Ascites	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Crohn's disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Diarrhaea haemorrhagic	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Gastritis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Bile acid malabsorption	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Hypothermia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Tenderness	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Adverse drug reaction	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Non-cardiac chest pain	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent thrombosis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.9% 5/170 • Number of events 5 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Complication associated with device	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Peripheral swelling	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	9.4% 16/170 • Number of events 17 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Chest pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Oedema peripheral	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Chills	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Facial pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Fatigue	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Influenza like illness	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Injection site bruising	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Injection site pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Oedema	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent occlusion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Puncture site hemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent stenosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Localized oedema	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
General disorders Vascular stent restenosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Lower respiratory tract infection	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Pharyngitis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Infected skin ulcer	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Pneumonia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Cellulitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Parotitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Postoperative wound infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Sepsis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Tinea cruris	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Infected cyst	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Respiratory tract infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Infected varicose vein	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Urinary tract infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Fungal skin infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Infections and infestations Root canal infection	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Laceration	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Peripheral nerve injury	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Contusion	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Thermal burn	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Post procedural hematoma	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Procedural headache	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Post procedural constipation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular access site hemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Injury, poisoning and procedural complications Vascular access site pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Hemoglobin decreased	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Oxygen saturation decreased	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Weight increased	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Antiphospholipid antibodies positive	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Blood creatinine increased	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations International normalised ratio increased	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Nuclear magnetic resonance imaging brain abnormal	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Venous pressure increased	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Investigations Cyst aspiration	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Dehydration	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Hyponatremia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 2/30 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Back pain	6.7% 2/30 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	8.8% 15/170 • Number of events 16 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 2/30 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	10.0% 17/170 • Number of events 21 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Costochondritis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Groin pain	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Tendon pain	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	2.9% 5/170 • Number of events 5 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Lethargy	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Paraesthesia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Syncope	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Dizziness	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Headache	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Amnesia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Burning sensation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Carotid artery aneurysm	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Facial paralysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Loss of consciousness	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders Seizure	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Nervous system disorders VIth nerve paralysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Productive cough	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Dyspnaea	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Abortion induced	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Venous angioplasty	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Thrombolysis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Varicose vein operation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Joint fluid drainage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Vena cava filter insertion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Vena cava filter removal	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Vascular stent insertion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Venous stent insertion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Hyperemia	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.00% 0/170 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Hypotension	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Thrombosis	3.3% 1/30 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Hematoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Haematoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Deep vein thrombosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Peripheral coldness	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Hemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Peripheral venous disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	9.4% 16/170 • Number of events 25 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Phlebitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Axillary vein thrombosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Hypertension	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Lymphoedema	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Thrombophlebitis superficial	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Surgical and medical procedures Varicose vein	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Vasculitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Post thrombotic syndrome	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Subclavian vein thrombosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Varicose ulceration	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Vascular disorders Vascular insufficiency	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Endocrine disorders Thyroid mass	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Hepatobiliary disorders Hepatitis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Immune system disorders Drug hypersensitivity	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Pregnancy, puerperium and perinatal conditions Blighted ovum	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Psychiatric disorders Phonophobia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Psychiatric disorders Drug use disorder	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 7 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Psychiatric disorders Anxiety	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Haematuria	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Nephrolithiasis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Renal cyst	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Renal and urinary disorders Acute kidney injury	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Reproductive system and breast disorders Pelvic congestion	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Reproductive system and breast disorders Menorrhagia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Reproductive system and breast disorders Scrotal pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.8% 3/170 • Number of events 4 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Blister	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 3 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Social circumstances Homeless	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Product Issues Device dislocation	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Product Issues Stent malfunction	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	0.59% 1/170 • Number of events 1 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/30 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.	1.2% 2/170 • Number of events 2 • Adverse event data were collected to one year post-implant, up to 12 months. Serious adverse event data were collected to one year post-implant, and will be collected up to 60 months.

Additional Information

Nancy O'Connell, Sr. Clinical Research Manager

Boston Scientific

Phone: 763-494-2706

Email: nancy.oconnell@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place