Trial Outcomes & Findings for A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) (NCT NCT04647253)

NCT ID: NCT04647253

Last Updated: 2026-02-03

Results Overview

The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 600 participants
• Primary outcome timeframe: 12-month
• Results posted on: 2026-02-03

Participant Flow

Participant milestones

Measure	AGENT DCB Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	Commercially Available, PTCA Dilation Catheter PTCA balloon catheter: PTCA balloon catheter
Overall Study STARTED	406	194
Overall Study COMPLETED	373	176
Overall Study NOT COMPLETED	33	18

Reasons for withdrawal

Measure	AGENT DCB Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	Commercially Available, PTCA Dilation Catheter PTCA balloon catheter: PTCA balloon catheter
Overall Study Death ≤ 365 Days	16	7
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	7	2
Overall Study Missed 12-Month Visit	9	7
Overall Study Death > 365 days and ≤ 395 days with no 12-month clinical follow-up performed	1	1

Baseline Characteristics

Number analyzed excludes subjects listed as unknown

Baseline characteristics by cohort

Measure	AGENT DCB n=406 Participants Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	Commercially Available, PTCA Dilation Catheter n=194 Participants PTCA balloon catheter: PTCA balloon catheter	Total n=600 Participants Total of all reporting groups
Age, Continuous	68.42 years STANDARD_DEVIATION 9.79 • n=406 Participants	67.90 years STANDARD_DEVIATION 9.68 • n=194 Participants	68.25 years STANDARD_DEVIATION 9.75 • n=600 Participants
Sex: Female, Male Female	104 Participants n=406 Participants	53 Participants n=194 Participants	157 Participants n=600 Participants
Sex: Female, Male Male	302 Participants n=406 Participants	141 Participants n=194 Participants	443 Participants n=600 Participants
Race/Ethnicity, Customized American Indian or Alaska native	0 Participants n=406 Participants	1 Participants n=194 Participants	1 Participants n=600 Participants
Race/Ethnicity, Customized Asian	9 Participants n=406 Participants	6 Participants n=194 Participants	15 Participants n=600 Participants
Race/Ethnicity, Customized Black, of African heritage	32 Participants n=406 Participants	10 Participants n=194 Participants	42 Participants n=600 Participants
Race/Ethnicity, Customized Caucasian	304 Participants n=406 Participants	148 Participants n=194 Participants	452 Participants n=600 Participants
Race/Ethnicity, Customized Hispanic or Latino	26 Participants n=406 Participants	9 Participants n=194 Participants	35 Participants n=600 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=406 Participants	1 Participants n=194 Participants	2 Participants n=600 Participants
Race/Ethnicity, Customized Other	16 Participants n=406 Participants	3 Participants n=194 Participants	19 Participants n=600 Participants
Race/Ethnicity, Customized Not Disclosed	23 Participants n=406 Participants	18 Participants n=194 Participants	41 Participants n=600 Participants
Region of Enrollment United States	406 participants n=406 Participants	194 participants n=194 Participants	600 participants n=600 Participants
Body Mass Index	30.01 kg/m2 STANDARD_DEVIATION 5.53 • n=396 Participants • Number analyzed excludes subjects listed as unknown	30.10 kg/m2 STANDARD_DEVIATION 5.85 • n=191 Participants • Number analyzed excludes subjects listed as unknown	30.04 kg/m2 STANDARD_DEVIATION 5.64 • n=587 Participants • Number analyzed excludes subjects listed as unknown
Current Diabetes Mellitus	206 Participants n=404 Participants • Number analyzed excludes subjects listed as unknown	97 Participants n=194 Participants • Number analyzed excludes subjects listed as unknown	303 Participants n=598 Participants • Number analyzed excludes subjects listed as unknown
History of Myocardial Infarction	198 Participants n=398 Participants • Number analyzed excludes subjects listed as unknown	95 Participants n=190 Participants • Number analyzed excludes subjects listed as unknown	293 Participants n=588 Participants • Number analyzed excludes subjects listed as unknown
Stent Layer in Target Lesion Single Layer	230 Participants n=406 Participants	112 Participants n=194 Participants	342 Participants n=600 Participants
Stent Layer in Target Lesion Multiple Layers	176 Participants n=406 Participants	82 Participants n=194 Participants	258 Participants n=600 Participants

PRIMARY outcome

Timeframe: 12-month

Population: The number of participants analyzed excludes subjects with insufficient follow up (i.e. subjects were followed less than 335 days post-procedure) and without experiencing 12-month TLF

The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death

Outcome measures

Measure	AGENT DCB n=390 Participants Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	Commercially Available, PTCA Dilation Catheter n=186 Participants PTCA balloon catheter: PTCA balloon catheter
Number of Participants With Target Lesion Failure	71 Participants	54 Participants

Adverse Events

AGENT DCB

Serious events: 226 serious events

Other events: 79 other events

Deaths: 17 deaths

Commercially Available, PTCA Dilation Catheter

Serious events: 113 serious events

Other events: 50 other events

Deaths: 8 deaths

Serious adverse events

Measure	AGENT DCB n=406 participants at risk Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	Commercially Available, PTCA Dilation Catheter n=194 participants at risk PTCA balloon catheter: PTCA balloon catheter
Cardiac disorders Angina unstable	8.6% 35/406 • Number of events 43 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	12.9% 25/194 • Number of events 36 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Angina pectoris	9.9% 40/406 • Number of events 43 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	11.9% 23/194 • Number of events 28 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Acute myocardial infarction	5.2% 21/406 • Number of events 25 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	7.2% 14/194 • Number of events 16 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Coronary artery disease	5.2% 21/406 • Number of events 21 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	5.7% 11/194 • Number of events 12 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Atrial fibrillation	3.4% 14/406 • Number of events 16 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.6% 5/194 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiac failure	2.5% 10/406 • Number of events 17 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiac failure congestive	1.7% 7/406 • Number of events 8 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	4.1% 8/194 • Number of events 10 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Myocardial infarction	1.7% 7/406 • Number of events 7 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Acute coronary syndrome	1.2% 5/406 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiac failure acute	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.1% 4/194 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Left ventricular failure	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Atrial flutter	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Coronary artery stenosis	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Ischaemic cardiomyopathy	0.99% 4/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Ventricular fibrillation	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Aortic valve stenosis	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Atrioventricular block second degree	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Bradycardia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiogenic shock	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Arteriosclerosis coronary artery	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Bundle branch block right	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiac arrest	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiac tamponade	0.25% 1/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiomyopathy	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Coronary artery perforation	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Pericardial effusion	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Sinus node dysfunction	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Ventricular tachycardia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Acute left ventricular failure	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Atrioventricular block complete	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiac valve disease	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardio-respiratory arrest	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Cardiorenal syndrome	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Chronic left ventricular failure	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Coronary artery dissection	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Coronary artery occlusion	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Mitral valve incompetence	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Mitral valve stenosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Myocardial ischaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Tachycardia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Torsade de pointes	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Cardiac disorders Ventricular extrasystoles	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Pneumonia	2.2% 9/406 • Number of events 10 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.6% 5/194 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations COVID-19	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Cellulitis	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Urinary tract infection	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Appendicitis	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations COVID-19 pneumonia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Sepsis	0.99% 4/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Diverticulitis	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Upper respiratory tract infection	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Abdominal abscess	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Abscess limb	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Arthritis infective	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Bacterial sepsis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Bronchitis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Catheter site abscess	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Clostridium difficile infection	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Cystitis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Enterococcal bacteraemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Gastroenteritis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Influenza	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Mediastinitis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Necrotising fasciitis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Osteomyelitis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Purulence	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Pyelonephritis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Respiratory tract infection	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Septic shock	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Staphylococcal bacteraemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Subcutaneous abscess	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Urosepsis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Viral infection	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Wound infection staphylococcal	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.2% 5/406 • Number of events 10 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.1% 4/194 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.99% 4/406 • Number of events 8 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 6/406 • Number of events 6 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.99% 4/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Emphysema	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Laryngeal mass	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Respiratory, thoracic and mediastinal disorders Wheezing	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Non-cardiac chest pain	2.7% 11/406 • Number of events 11 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.6% 5/194 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Chest pain	1.2% 5/406 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Vascular stent stenosis	1.2% 5/406 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Catheter site haematoma	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Catheter site haemorrhage	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Death of unknown cause	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Fatigue	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Multiple organ dysfunction syndrome	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Oedema peripheral	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Vascular stent thrombosis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Chest discomfort	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Gait disturbance	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Mass	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Medical device site thrombosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Pain	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Pyrexia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Stenosis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.99% 4/406 • Number of events 6 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Dental caries	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Intestinal ischaemia	0.49% 2/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Abdominal pain	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Oesophageal stenosis	0.25% 1/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Diarrhoea	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Inguinal hernia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Nausea	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Vomiting	0.25% 1/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Abdominal distension	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Acquired oesophageal web	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Colitis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Constipation	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Diverticulum	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Dyspepsia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Enteritis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Eructation	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Gastritis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Gastritis erosive	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Hiatus hernia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Intestinal obstruction	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Intussusception	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Gastrointestinal disorders Toothache	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cerebrovascular accident	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.1% 4/194 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Syncope	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Dizziness	0.99% 4/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Carpal tunnel syndrome	0.25% 1/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Presyncope	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Encephalopathy	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Paraesthesia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Seizure	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Transient ischaemic attack	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Aphasia	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Carotid artery stenosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cerebral haemorrhage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cerebral infarction	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cerebrospinal fluid leakage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cervical radiculopathy	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cluster headache	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Cranial nerve paralysis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Dyskinesia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Hemianopia homonymous	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Hypoaesthesia	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Lacunar infarction	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Lumbar radiculopathy	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Metabolic encephalopathy	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Myelopathy	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Myoclonus	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Optic perineuritis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Sciatica	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Subarachnoid haemorrhage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Thalamic infarction	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Nervous system disorders Vocal cord paralysis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Hypotension	2.0% 8/406 • Number of events 8 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Hypertension	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.1% 4/194 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Aortic stenosis	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Haematoma	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Haemodynamic instability	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Orthostatic hypotension	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Peripheral arterial occlusive disease	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Peripheral artery occlusion	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Peripheral ischaemia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Deep vein thrombosis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Dry gangrene	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Hypertensive urgency	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Intermittent claudication	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Orthostatic hypertension	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Peripheral vascular disorder	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Shock	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Shock haemorrhagic	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Vascular disorders Thrombophlebitis superficial	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Fall	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Plaque shift	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Contusion	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Procedural pain	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Skin laceration	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Anaemia postoperative	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Craniocerebral injury	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Facial bones fracture	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Subdural haematoma	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Burns third degree	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Fibula fracture	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Hand fracture	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Hip fracture	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Musculoskeletal injury	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Post procedural haemorrhage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Postoperative hypertension	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Procedural shock	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Tibia fracture	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Vascular procedure complication	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Injury, poisoning and procedural complications Wound	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hyperglycaemia	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.6% 5/194 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hypokalaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Metabolic acidosis	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Electrolyte imbalance	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hyponatraemia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Lactic acidosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Hepatobiliary disorders Cholelithiasis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Cachexia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Diabetic ketoacidosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Fluid overload	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hyperkalaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hypertriglyceridaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hypoalbuminaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hypomagnesaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Hypophosphataemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Iron deficiency	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Starvation ketoacidosis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Acute kidney injury	2.5% 10/406 • Number of events 12 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.5% 3/194 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Urinary retention	1.2% 5/406 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders End stage renal disease	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Ureterolithiasis	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Urinary incontinence	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Bladder outlet obstruction	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Cystitis haemorrhagic	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Haematuria	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Renal failure	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Urethral cyst	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Urethral obstruction	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Renal and urinary disorders Urinary bladder polyp	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Anaemia	1.7% 7/406 • Number of events 7 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	2.6% 5/194 • Number of events 5 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Blood loss anaemia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Anaemia of chronic disease	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Coagulopathy	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Febrile neutropenia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Haemolytic anaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Leukocytosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Normocytic anaemia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Blood and lymphatic system disorders Thrombocytopenia	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.99% 4/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Arthralgia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Back pain	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Myopathy	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Pathological fracture	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations SARS-CoV-2 test positive	0.74% 3/406 • Number of events 3 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Acid base balance abnormal	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Blood glucose abnormal	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Blood pressure diastolic increased	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Coagulation test abnormal	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Electrocardiogram QT prolonged	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Fibrin D dimer increased	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations International normalised ratio abnormal	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Low density lipoprotein increased	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Pulmonary function test decreased	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Pulse absent	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Investigations Urine output decreased	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia stage 3	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Skin and subcutaneous tissue disorders Decubitus ulcer	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Post transplant lymphoproliferative disorder	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Eye disorders Cataract	0.74% 3/406 • Number of events 4 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Eye disorders Vision blurred	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Eye disorders Macular hole	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Eye disorders Visual impairment	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Skin and subcutaneous tissue disorders Blister	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Skin and subcutaneous tissue disorders Granuloma annulare	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Skin and subcutaneous tissue disorders Pruritus	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Psychiatric disorders Agitation	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Psychiatric disorders Confusional state	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Psychiatric disorders Depression	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Psychiatric disorders Mental status changes	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Ear and labyrinth disorders Vertigo	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Hepatobiliary disorders Biliary obstruction	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Hepatobiliary disorders Cholecystitis acute	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Reproductive system and breast disorders Benign prostatic hyperplasia	0.49% 2/406 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Reproductive system and breast disorders Prostatitis	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Surgical and medical procedures Breast conserving surgery	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Surgical and medical procedures Mitral valve replacement	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Surgical and medical procedures Spinal operation	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Immune system disorders Hypersensitivity	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	1.0% 2/194 • Number of events 2 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Congenital, familial and genetic disorders Pyloric stenosis	0.25% 1/406 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.00% 0/194 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Product Issues Device lead damage	0.00% 0/406 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	0.52% 1/194 • Number of events 1 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)

Other adverse events

Measure	AGENT DCB n=406 participants at risk Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	Commercially Available, PTCA Dilation Catheter n=194 participants at risk PTCA balloon catheter: PTCA balloon catheter
Cardiac disorders Angina pectoris	9.9% 40/406 • Number of events 42 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	10.3% 20/194 • Number of events 21 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
Infections and infestations Covid-19	8.4% 34/406 • Number of events 37 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	8.8% 17/194 • Number of events 19 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)
General disorders Non-cardiac chest pain	2.5% 10/406 • Number of events 11 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)	7.7% 15/194 • Number of events 17 • All-Cause Mortality was assessed up to 395 days post procedure. Serious and Other Adverse Events were monitored up to 365 days post procedure. Adverse events were assessed at each follow-up visit (30 days, 6 months, and 12 months)

Additional Information

Patricia O'Mara

Boston Scientific

Phone: 518-744-0046

Email: patricia.omara@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER