Trial Outcomes & Findings for Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries (NCT NCT01870401)

NCT ID: NCT01870401

Last Updated: 2022-02-09

Results Overview

The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 442 participants
• Primary outcome timeframe: 30 days post index procedure
• Results posted on: 2022-02-09

Participant Flow

Participants were recruited from medical clinics and hospitals between June 2013 and January 2018. The first participant was enrolled on June 3, 2013 and the last participant enrolled was on December 12, 2017.

Participant milestones

Measure	Lutonix DCB Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	Standard Balloon Angioplasty Catheter Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Overall Study STARTED	287	155
Overall Study COMPLETED	137	59
Overall Study NOT COMPLETED	150	96

Reasons for withdrawal

Measure	Lutonix DCB Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	Standard Balloon Angioplasty Catheter Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Overall Study Death	48	24
Overall Study Withdrawal by Subject	39	26
Overall Study Lost to Follow-up	19	14
Overall Study Other	9	7
Overall Study On-going in the Study	35	25

Baseline Characteristics

Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Baseline characteristics by cohort

Measure	Lutonix DCB n=287 Participants Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	Standard Balloon Angioplasty Catheter n=155 Participants Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	Total n=442 Participants Total of all reporting groups
Age, Continuous	72.9 years STANDARD_DEVIATION 9.65 • n=93 Participants	72.9 years STANDARD_DEVIATION 9.62 • n=4 Participants	72.9 years STANDARD_DEVIATION 9.63 • n=27 Participants
Sex: Female, Male Female	85 Participants n=93 Participants	51 Participants n=4 Participants	136 Participants n=27 Participants
Sex: Female, Male Male	202 Participants n=93 Participants	104 Participants n=4 Participants	306 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	25 Participants n=93 Participants	15 Participants n=4 Participants	40 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	33 Participants n=93 Participants	12 Participants n=4 Participants	45 Participants n=27 Participants
Race/Ethnicity, Customized White	226 Participants n=93 Participants	127 Participants n=4 Participants	353 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	178 participants n=93 Participants	97 participants n=4 Participants	275 participants n=27 Participants
Region of Enrollment Europe	80 participants n=93 Participants	42 participants n=4 Participants	122 participants n=27 Participants
Region of Enrollment Japan	25 participants n=93 Participants	15 participants n=4 Participants	40 participants n=27 Participants
Region of Enrollment Canada	4 participants n=93 Participants	1 participants n=4 Participants	5 participants n=27 Participants
Weight	82.6 kg STANDARD_DEVIATION 21.15 • n=93 Participants	81.9 kg STANDARD_DEVIATION 20.29 • n=4 Participants	82.3 kg STANDARD_DEVIATION 20.83 • n=27 Participants
Height	170 cm STANDARD_DEVIATION 10.07 • n=93 Participants	170 cm STANDARD_DEVIATION 10.65 • n=4 Participants	170 cm STANDARD_DEVIATION 10.26 • n=27 Participants
Body Mass Index	28.4 kg/m^2 STANDARD_DEVIATION 6.31 • n=93 Participants	28.0 kg/m^2 STANDARD_DEVIATION 5.65 • n=4 Participants	28.2 kg/m^2 STANDARD_DEVIATION 6.08 • n=27 Participants

PRIMARY outcome

Timeframe: 30 days post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.

Outcome measures

Measure	Lutonix DCB n=286 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=155 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure.	284 Participants	154 Participants

PRIMARY outcome

Timeframe: 6 months post-index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb.

Outcome measures

Measure	Lutonix DCB n=269 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=137 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure.	201 Participants	88 Participants

SECONDARY outcome

Timeframe: At time of index procedure

Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation ≤ 30% was reported.

Outcome measures

Measure	Lutonix DCB n=106 Lesions Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=60 Lesions Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Lesions Considered Technical Success at Time of Index Procedure	61.3 percentage of lesions Interval 51.4 to 70.6	58.3 percentage of lesions Interval 44.9 to 70.9

SECONDARY outcome

Timeframe: At time of Index Procedure

A success is determined if there is restoration of at least 1 infrapopliteal artery with residual stenosis ≤ 30% (or ≤ 50% depending upon the version of the protocol) and inline outflow to the foot, irrespective of device success, and without a major adverse event during the index procedure.

Outcome measures

Measure	Lutonix DCB n=287 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=155 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Procedures With Procedural Success at Time of Index Procedure.	84.0 Percentage of Procedures Interval 79.5 to 87.9	81.4 Percentage of Procedures Interval 74.8 to 86.8

SECONDARY outcome

Timeframe: 30 days post index procedure

Population: Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure compared to baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change in EuroQol (EQ-5D) scores at 30 days, 6, and 12 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=287 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=155 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. 6 months post index procedure	0.07 Scores on a scale Standard Deviation 0.300	0.05 Scores on a scale Standard Deviation 0.297
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. 12 months post index procedure	0.09 Scores on a scale Standard Deviation 0.284	0.12 Scores on a scale Standard Deviation 0.267
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. 30-days Post Index Procedure	1.10 Scores on a scale Standard Deviation 0.458	0.53 Scores on a scale Standard Deviation 0.533

SECONDARY outcome

Timeframe: 12 months post-index procedure

Population: Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. The number of wounds analyzed at 6 and 12 months post-index procedure includes wounds that may have appeared (new wounds) since the previous time period reporting.

Outcome measures

Measure	Lutonix DCB n=211 Wounds Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=114 Wounds Standard Uncoated PTA Catheter Uncoated PTA Catheter
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure 30-days Post Index Procedure	49 Wounds	24 Wounds
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure 6 months post index procedure	61 Wounds	45 Wounds
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure 12 months post index procedure	42 Wounds	17 Wounds

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Outcome measures

Measure	Lutonix DCB n=130 Non-Healed Wounds Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=61 Non-Healed Wounds Standard Uncoated PTA Catheter Uncoated PTA Catheter
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 30-days Post Index Procedure · Improving	90 Non-Healed Wounds	37 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 30-days Post Index Procedure · Stagnant	24 Non-Healed Wounds	16 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 30-days Post Index Procedure · Worsening	16 Non-Healed Wounds	8 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 6 months post index procedure · Improving	26 Non-Healed Wounds	6 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 6 months post index procedure · Stagnant	13 Non-Healed Wounds	7 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 6 months post index procedure · Worsening	12 Non-Healed Wounds	4 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 12 months post index procedure · Improving	18 Non-Healed Wounds	8 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 12 months post index procedure · Stagnant	9 Non-Healed Wounds	4 Non-Healed Wounds
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure. 12 months post index procedure · Worsening	1 Non-Healed Wounds	2 Non-Healed Wounds

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: Participants may have more than one wound type or wounds in more than one location. The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=100 Wounds Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=67 Wounds Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure · Recurrent Wounds	4 Wounds	1 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure · Existing Wounds	94 Wounds	46 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure · New Wounds	5 Wounds	12 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure · Recurrent Wounds	1 Wounds	0 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure · Existing Wounds	62 Wounds	33 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure · New Wounds	20 Wounds	10 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure · Recurrent Wounds	1 Wounds	1 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure · Existing Wounds	37 Wounds	16 Wounds
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure · New Wounds	9 Wounds	9 Wounds

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure compared to baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 36 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=287 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=155 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 30-days Post Index Procedure · Improved	161 Participants	83 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 30-days Post Index Procedure · Same	100 Participants	59 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 30-days Post Index Procedure · Worsened	2 Participants	2 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 6 months post index procedure · Improved	179 Participants	98 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 6 months post index procedure · Same	58 Participants	21 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 6 months post index procedure · Worsened	6 Participants	1 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 12 months post index procedure · Improved	176 Participants	90 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 12 months post index procedure · Same	39 Participants	16 Participants
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 12 months post index procedure · Worsened	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The composite endpoint of freedom from above ankle amputation (CEC-adjudicated), unhealed wound (presence of wound vs. no wound), ischemic rest pain (Rutherford category 4 or higher), target vessel occlusion (based on DUS and/or angiograph), and clinically-driven TVR (CEC-adjudicated).

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=287 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=155 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure	93 Participants	45 Participants
Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure	98 Participants	49 Participants
Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure	71 Participants	53 Participants

SECONDARY outcome

Timeframe: 30 days and at 6 and 12 months

Population: The number of participants or lesions may vary depending on the number of participants/lesions for which data was available at the given time-point analysis.

Primary patency is defined as the absence of both total occlusion (100% diameter stenosis) in all of the target lesions in a flow pathway as well as a clinically-driven Target Lesion Revascularization (TLR).

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=261 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=127 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure 30-days Post Index Procedure	97.4 Percentage of Participants Interval 94.6 to 98.7	94.8 Percentage of Participants Interval 89.4 to 97.5
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure 6 months post index procedure	85.3 Percentage of Participants Interval 80.2 to 89.1	72.2 Percentage of Participants Interval 63.3 to 79.3
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure 12 months post procedure	58.1 Percentage of Participants Interval 51.5 to 64.2	60.0 Percentage of Participants Interval 50.6 to 68.2

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants or lesions may vary depending on the number of participants/lesions for which data was available at the given time-point analysis.

Primary patency with exclusion of early mechanical recoil of the target flow pathway is defined as the absence of both total occlusion (100% diameter stenosis) of the target lesions and clinically-driven TLR events > 30 days.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=298 Lesions Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=159 Lesions Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure 30-days Post Index Procedure	100 Percentage of Lesions Interval 100.0 to 100.0	100 Percentage of Lesions Interval 100.0 to 100.0
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure 6 months post index procedure	88.0 Percentage of Lesions Interval 83.5 to 91.3	73.8 Percentage of Lesions Interval 65.5 to 80.4
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure 12 months post index procedure	61.7 Percentage of Lesions Interval 55.4 to 67.3	63.0 Percentage of Lesions Interval 54.2 to 70.6

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis

The secondary patency of the target lesion is defined as the absence of total occlusion (100% diameter stenosis) of the target lesions based on angiography (if performed) or ultrasound as analyzed by the angiographic Core Lab.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=293 Lesions Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=184 Lesions Standard Uncoated PTA Catheter Uncoated PTA Catheter
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure 30-days Post Index Procedure	284 Lesions	146 Lesions
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure 6 months post index procedure	217 Lesions	103 Lesions
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure 12 months post index procedure	144 Lesions	91 Lesions

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure compared to baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change from baseline values. The Toe Brachial Index (TBI) is defined as a ratio of toe to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=119 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=128 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 30-days Post Index Procedure	0.20 Ratio Standard Deviation 0.25	0.28 Ratio Standard Deviation 0.42
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 6 months post index procedure	0.15 Ratio Standard Deviation 0.24	0.17 Ratio Standard Deviation 0.43
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 12 months post index procedure	0.12 Ratio Standard Deviation 0.23	0.18 Ratio Standard Deviation 0.40

SECONDARY outcome

Timeframe: 30 days, and at 6 and 12 months compared to baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=237 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=128 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 30-days Post Index Procedure	0.23 Ratio Standard Deviation 0.36	0.28 Ratio Standard Deviation 0.42
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 6 months post index procedure	0.16 Ratio Standard Deviation 0.36	0.17 Ratio Standard Deviation 0.43
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 12 months post index procedure	0.11 Ratio Standard Deviation 0.36	0.18 Ratio Standard Deviation 0.40

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure compared to baseline

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days 6 and 12 months, compared to baseline assessment scores.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=238 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=120 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 30-days Post Index Procedure	0.3 score on a scale Standard Deviation 18.13	1.1 score on a scale Standard Deviation 17.46
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 6 months post index procedure	2.9 score on a scale Standard Deviation 21.55	3.6 score on a scale Standard Deviation 20.27
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 12 months post index procedure	2.7 score on a scale Standard Deviation 22.10	2.3 score on a scale Standard Deviation 20.23

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=170 Target Lesions Revascularization Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=75 Target Lesions Revascularization Standard Uncoated PTA Catheter Uncoated PTA Catheter
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure	101 participants	53 participants
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure	5 participants	6 participants
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure	36 participants	36 participants

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: Data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Outcome measures

Measure	Lutonix DCB n=175 Target Vessel Revascularization Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=79 Target Vessel Revascularization Standard Uncoated PTA Catheter Uncoated PTA Catheter
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure	5 Target Vessel Revascualarization	6 Target Vessel Revascualarization
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure	37 Target Vessel Revascualarization	38 Target Vessel Revascualarization
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure	105 Target Vessel Revascualarization	57 Target Vessel Revascualarization

SECONDARY outcome

Timeframe: 30 days and at 6 and 12 months

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Limb salvage defined as no amputation of target limb.

Outcome measures

Measure	Lutonix DCB n=282 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=153 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure 30-days Post Index Procedure	100 percentage of participants Interval 100.0 to 100.0	100 percentage of participants Interval 100.0 to 100.0
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure 6 months post index procedure	98.9 percentage of participants Interval 96.6 to 99.6	98.0 percentage of participants Interval 93.9 to 99.4
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure 12 months post index procedure	97.4 percentage of participants Interval 94.5 to 98.7	98.0 percentage of participants Interval 93.9 to 99.4

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Defined as amputation that was below the ankle, including digit amputation. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=274 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=148 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure	95.8 Percentage of participants Interval 92.7 to 97.6	95.5 Percentage of participants Interval 90.8 to 97.8
Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure	88.6 Percentage of participants Interval 84.2 to 91.8	88.2 Percentage of participants Interval 81.9 to 92.4
Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure	86.3 Percentage of participants Interval 81.6 to 89.8	83.1 Percentage of participants Interval 76.0 to 88.3

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

The overall burden of BTK reinterventions was defined as the total number of BTK index-limb re-interventions and major amputations for each time point.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=365 Limb Reintervention Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=164 Limb Reintervention Standard Uncoated PTA Catheter Uncoated PTA Catheter
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. 6 months post index procedure	112 Limb Reintervention	88 Limb Reintervention
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. 12 months post index procedure	235 Limb Reintervention	124 Limb Reintervention
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. 30-days Post Index Procedure	27 Limb Reintervention	22 Limb Reintervention

SECONDARY outcome

Timeframe: 30 days, 6 and 12 months post index procedure

Population: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.

Outcome measures

Measure	Lutonix DCB n=287 Participants Lutonix Paclitaxel Drug Coated Balloon Lutonix DCB	PTA Catheter n=155 Participants Standard Uncoated PTA Catheter Uncoated PTA Catheter
Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure 30-days Post Index Procedure	93.4 Percentage of participants Interval 89.8 to 95.7	90.3 Percentage of participants Interval 84.5 to 94.0
Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure 6 months post index procedure	78.9 Percentage of participants Interval 73.6 to 83.2	69.6 Percentage of participants Interval 61.6 to 76.3
Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure 12 months post index procedure	56.8 Percentage of participants Interval 50.6 to 62.5	58.0 Percentage of participants Interval 49.5 to 65.6

Adverse Events

Lutonix DCB

Serious events: 240 serious events

Other events: 106 other events

Deaths: 48 deaths

Standard Balloon Angioplasty Catheter

Serious events: 126 serious events

Other events: 45 other events

Deaths: 25 deaths

Serious adverse events

Measure	Lutonix DCB n=287 participants at risk Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	Standard Balloon Angioplasty Catheter n=155 participants at risk Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Renal and urinary disorders Urinary Retention	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Reproductive system and breast disorders Vaginal Haemorrhage	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.2% 5/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Anaemia	3.5% 10/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Anaemia Of Chronic Disease	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Heparin-Induced Thrombocytopenia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Hypochromic Anaemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Leukocytosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Nephrogenic Anaemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Acute Coronary Syndrome	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Acute Myocardial Infarction	4.9% 14/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	5.2% 8/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Angina Pectoris	2.8% 8/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.9% 6/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Angina Unstable	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Aortic Valve Disease	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Aortic Valve Stenosis	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Arrhythmia Supraventricular	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrial Fibrillation	3.5% 10/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.9% 6/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrial Flutter	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrial Tachycardia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrioventricular Block	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrioventricular Block Complete	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrioventricular Block Second Degree	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Bradyarrhythmia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Bundle Branch Block Left	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiac Arrest	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiac Failure	3.8% 11/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.2% 5/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiac Failure Acute	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiac Failure Chronic	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiac Failure Congestive	7.3% 21/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	7.7% 12/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardio-Respiratory Arrest	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiogenic Shock	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiomegaly	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiomyopathy	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Cardiopulmonary Failure	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Coronary Artery Disease	3.8% 11/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.2% 5/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Coronary Artery Stenosis	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Ischaemic Cardiomyopathy	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Left Ventricular Failure	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Mitral Valve Incompetence	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Myocardial Infarction	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Myocardial Ischaemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Pericarditis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Pulseless Electrical Activity	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Right Ventricular Failure	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Sick Sinus Syndrome	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Tachycardia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Tricuspid Valve Disease	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Tricuspid Valve Incompetence	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Ventricular Arrhythmia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Ventricular Extrasystoles	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Ventricular Tachycardia	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Congenital, familial and genetic disorders Buried Penis Syndrome	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Congenital, familial and genetic disorders Hydrocele	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Ear and labyrinth disorders Vertigo	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Eye disorders Angle Closure Glaucoma	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Eye disorders Cataract	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Eye disorders Diabetic Retinopathy	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Eye disorders Eye Haemorrhage	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Abdominal Hernia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Abdominal Pain	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Abdominal Wall Haematoma	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Colitis Ischaemic	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Constipation	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Dental Caries	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Diarrhoea	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Duodenal Ulcer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Dyspepsia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Dysphagia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Faecal Incontinence	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Gastrointestinal Haemorrhage	2.4% 7/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Gastrointestinal Oedema	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Ileus Paralytic	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Inguinal Hernia, Obstructive	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Intestinal Ischaemia	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Intestinal Mass	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Intestinal Obstruction	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Ischaemic Enteritis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Large Intestine Polyp	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Mesenteric Artery Stenosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Nausea	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Oesophagitis Ulcerative	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Retroperitoneal Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Vomiting	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Adverse Drug Reaction	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Chest Pain	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Death	2.8% 8/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Device Battery Issue	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Device Dislocation	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Device Occlusion	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Disease Progression	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Impaired Healing	2.8% 8/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Local Swelling	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Non-Cardiac Chest Pain	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Oedema Peripheral	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Pyrexia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Systemic Inflammatory Response Syndrome	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Vessel Puncture Site Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Vessel Puncture Site Haemorrhage	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Hepatobiliary disorders Bile Duct Stone	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Hepatobiliary disorders Cholecystitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Hepatobiliary disorders Cholecystitis Acute	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Hepatobiliary disorders Cholelithiasis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Immune system disorders Drug Hypersensitivity	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Abscess	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Abscess Limb	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Appendicitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Arthritis Bacterial	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Atypical Pneumonia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Bacteraemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Bronchitis	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Bronchopulmonary Aspergillosis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Cellulitis	4.5% 13/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.9% 6/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Clostridium Difficile Colitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Clostridium Difficile Infection	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Cystitis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Diabetic Foot Infection	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Diverticulitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Emphysematous Cystitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Endocarditis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Erysipelas	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Gangrene	7.7% 22/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	7.1% 11/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Gastritis Viral	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Gastroenteritis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Groin Abscess	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Herpes Zoster	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Infected Skin Ulcer	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Influenza	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Intervertebral Discitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Localised Infection	3.5% 10/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.2% 5/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Lung Abscess	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Osteomyelitis	7.3% 21/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	10.3% 16/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Paronychia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Pneumonia	5.2% 15/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	4.5% 7/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Pneumonia Bacterial	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Postoperative Wound Infection	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Pyelonephritis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Sepsis	2.8% 8/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.2% 5/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Septic shock	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Serratia Bacteraemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Sputum Purulent	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Subcutaneous Abscess	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Urinary Tract Infection	3.1% 9/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.9% 6/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Urosepsis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Vaginal Infection	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Wound Infection	2.8% 8/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Anaemia Postoperative	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Coronary Artery Restenosis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Fall	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Femur Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Forearm Fracture	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Hand Fracture	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Hip Fracture	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Humerus Fracture	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Iatrogenic Injury	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Laceration	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Meniscus Injury	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Overdose	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Patella Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Peripheral Arterial Reocclusion	12.2% 35/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	7.1% 11/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	21.6% 62/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	23.2% 36/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Postoperative Wound Complication	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Radius Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Rib Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Skin Injury	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Subcutaneous Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Subdural Haematoma	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Tendon Rupture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Tibia Fracture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Traumatic Haematoma	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Vascular Graft Complication	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Vascular Graft Thrombosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Wound	5.2% 15/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.9% 6/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Wound Dehiscence	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Wound Haemorrhage	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Wound Necrosis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Blood Creatinine Increased	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Blood Culture Positive	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Blood Glucose Fluctuation	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Blood Pressure Decreased	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Haemoglobin Decreased	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Investigation	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Radioisotope Scan Abnormal	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Troponin Increased	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Decreased Appetite	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Dehydration	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Diabetes Mellitus	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Hyperglycaemia	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Hypoglycaemia	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Hypokalaemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Metabolism and nutrition disorders Malnutrition	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Arthritis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Bursitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Foot Deformity	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Joint Contracture	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Joint Effusion	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Myositis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.4% 7/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Soft Tissue Mass	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous Cell Lung Cancer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip And/Or Oral Cavity Cancer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal Cancer	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Lung	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Amnesia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Brain Stem Stroke	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Carotid Artery Stenosis	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Carpal Tunnel Syndrome	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Cerebral Haemorrhage	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Cerebral Infarction	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Cerebrovascular Accident	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Cerebrovascular Disorder	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Convulsion	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Dementia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Dizziness	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Embolic Stroke	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Encephalopathy	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Hemiparesis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Lacunar Infarction	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Metabolic Encephalopathy	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Parkinson's Disease	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Precerebral Artery Occlusion	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Somnolence	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Spinal Cord Compression	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Subarachnoid Haemorrhage	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Syncope	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Toxic Encephalopathy	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Transient ischaemic attack	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Vascular Dementia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Psychiatric disorders Anxiety	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Psychiatric disorders Depression	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Psychiatric disorders Mental Status Changes	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Psychiatric disorders Neglect Of Personal Appearance	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Bladder Mass	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Calculus Urinary	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Haematuria	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Nephropathy	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Nephropathy Toxic	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Obstructive Uropathy	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Pyuria	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Renal Artery Stenosis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Renal Failure	3.5% 10/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	4.5% 7/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Renal Failure Acute	4.2% 12/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Renal Impairment	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Ureteric Stenosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Respiratory Arrest	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	3.2% 5/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Diabetic Foot	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Diabetic Ulcer	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Dry Gangrene	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Leukocytoclastic Vasculitis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Pruritus	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Skin Necrosis	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Skin Ulcer	5.9% 17/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	7.7% 12/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Accelerated Hypertension	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Aortic Aneurysm	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Aortic Stenosis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Arterial Rupture	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Arteritis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Deep Vein Thrombosis	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Diabetic Macroangiopathy	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Embolism Arterial	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Extremity Necrosis	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Femoral Artery Occlusion	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Haemorrhage	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Hypertension	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Hypertensive Crisis	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Hypertensive Emergency	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Hypotension	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Intermittent Claudication	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Orthostatic Hypotension	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Arterial Occlusive Disease	20.2% 58/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	10.3% 16/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Artery Dissection	3.1% 9/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Artery Stenosis	20.2% 58/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	22.6% 35/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Artery Thrombosis	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Ischaemia	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Varicose Vein	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Vascular Insufficiency	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Vasospasm	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Venous Insufficiency	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Venous Thrombosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Vessel Perforation	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Bradycardia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Hypoaesthesia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Acute Ischemia Left Lower Leg	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Admission to Psychiatry	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Chest Pain Syndrome with Acute Moderate Pericardia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Claudication Left Leg	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Gangrene on Left Great Toe	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders I & D with Partial Left Hallux Amputation	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Occluded Left Sfa Stent	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Occlusion of Right At & Dp	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Occlusion of Left At and Stenosis of Left Tpt	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Profundus Stenosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Ulcerated Basalioma Left Eyelid	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.

Other adverse events

Measure	Lutonix DCB n=287 participants at risk Percutaneous transluminal angiography (PTA) will be performed using the Lutonix Drug Coated Balloon. Lutonix DCB Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.	Standard Balloon Angioplasty Catheter n=155 participants at risk Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used. Standard Balloon Angioplasty Catheter Percutaneous Transluminal Angiography: Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.
Injury, poisoning and procedural complications Scrotal Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Wound	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Subcutaneous Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	1.7% 5/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.9% 3/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Gangrene	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Osteomyelitis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Peripheral Arterial Reocclusion	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	1.0% 3/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	2.6% 4/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Procedural Pain	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Nervous system disorders Hypoaesthesia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Embolism Arterial	2.1% 6/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Arterial Occlusive Disease	2.4% 7/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Artery Dissection	3.5% 10/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral Artery Stenosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Peripheral artery thrombosis	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Vasospasm	3.8% 11/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	2.6% 4/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Blood and lymphatic system disorders Anaemia	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Acute Myocardial Infarction	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Atrial Fibrillation	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Cardiac disorders Myocardial Infarction	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Gastrointestinal disorders Retroperitoneal Haematoma	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Local Swelling	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Oedema Peripheral	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Puncture Site Haemorrhage	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Pyrexia	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Stent Malfunction	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Vessel Puncture Site Haematoma	2.4% 7/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Arthritis Bacterial	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Cellulitis	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Infections and infestations Localised Infection	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Injury, poisoning and procedural complications Incision Site Complication	0.70% 2/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Haemoglobin Decreased	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Investigations Urine Analysis Abnormal	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Psychiatric disorders Delirium	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Haematuria	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Nephropathy Toxic	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Renal and urinary disorders Renal Failure	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Blister	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Skin and subcutaneous tissue disorders Rash	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Arteriovenous Fistula	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Haematoma	1.4% 4/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Haemorrhage	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Hypertensive Crisis	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Hypotension	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.65% 1/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
Vascular disorders Vessel Perforation	0.35% 1/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	0.00% 0/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.
General disorders Worsening of Peripheral Artery Disease	0.00% 0/287 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.	1.3% 2/155 • Subjects with Serious Adverse Events by Body System and Preferred Term are presented through 36 Months and are Site-reported. All devices and procedure-related adverse events (AEs) were collected through 36 months post index procedure and are CEC adjudicated.

Additional Information

Lisa Erickson

Becton Dickinson

Phone: 763-463-2897

Email: Lisa.Erickson@bd.com

Results disclosure agreements

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