Trial Outcomes & Findings for Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (NCT NCT02729740)

NCT ID: NCT02729740

Last Updated: 2021-03-01

Results Overview

Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 995 participants
• Primary outcome timeframe: Immediate Post Procedure
• Results posted on: 2021-03-01

Participant Flow

Participant milestones

Measure	Penumbra Smart System Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Overall Study STARTED	995
Overall Study COMPLETED	864
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Measure	Penumbra Smart System Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Overall Study Early Termination	130
Overall Study Other	1

Baseline Characteristics

Number analyzed differs from overall total because Ethnicity was captured later in the study.

Baseline characteristics by cohort

Measure	Penumbra Smart System n=995 Participants Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Age, Continuous	59.6 years STANDARD_DEVIATION 13 • n=995 Participants
Sex: Female, Male Female	717 Participants n=995 Participants
Sex: Female, Male Male	278 Participants n=995 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=326 Participants • Number analyzed differs from overall total because Ethnicity was captured later in the study.
Ethnicity (NIH/OMB) Not Hispanic or Latino	293 Participants n=326 Participants • Number analyzed differs from overall total because Ethnicity was captured later in the study.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=326 Participants • Number analyzed differs from overall total because Ethnicity was captured later in the study.
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.
Race (NIH/OMB) Asian	6 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.
Race (NIH/OMB) Black or African American	43 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.
Race (NIH/OMB) White	256 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.
Race (NIH/OMB) More than one race	0 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=326 Participants • Measure Analysis Population Description: Number analyzed differs from overall total because Race was captured later in the study.

PRIMARY outcome

Timeframe: Immediate Post Procedure

Population: The analysis population (ITT) contains all 995 patients. 994 of 995 ITT patients have data on adequate occlusion at immediate post procedure.

Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.

Outcome measures

Measure	Penumbra Smart System n=994 Participants Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Number of Participants Achieving Adequate Occlusion Immediate Post Procedure	965 Participants

PRIMARY outcome

Timeframe: Immediate Post Procedure

Population: The analysis population is per device.

Re-access attempts due to catheter kick-out across all coils

Outcome measures

Measure	Penumbra Smart System n=5733 Coils Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout	317 Coils

PRIMARY outcome

Timeframe: Immediate Post Procedure

Outcome measures

Measure	Penumbra Smart System n=995 Participants Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure	26 Participants

PRIMARY outcome

Timeframe: One year from enrollment

Population: The number of participants analyzed is different from overall as these were subjects that returned for follow-up in the intent to treat population.

Outcome measures

Measure	Penumbra Smart System n=784 Participants Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Number of Participants Requiring Retreatment Through Follow-up	53 Participants

Adverse Events

Penumbra Smart System

Serious events: 277 serious events

Other events: 90 other events

Deaths: 60 deaths

Serious adverse events

Measure	Penumbra Smart System n=995 participants at risk Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Blood and lymphatic system disorders Anaemia	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Blood and lymphatic system disorders Leukocytosis	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Acute myocardial infarction	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Arteriospasm coronary	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Atrial fibrillation	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Atrial tachycardia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Atrioventricular block complete	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardiac arrest	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardiac disorder	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardiac failure	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardiac failure congestive	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardio-respiratory arrest	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardiogenic shock	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Cardiopulmonary failure	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Coronary artery disease	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Ischaemic cardiomyopathy	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Myocardial infarction	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Myocardial ischaemia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Cardiac disorders Stress cardiomyopathy	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Congenital, familial and genetic disorders Arteriovenous malformation	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Endocrine disorders Adrenal insufficiency	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Eye disorders Retinal hemorrhage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Abdominal distension	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Colitis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Colonic pseudo-obstruction	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Duodenal ulcer	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Dysphagia	0.70% 7/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Gastrointestinal ulcer	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Haematochezia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Intestinal obstruction	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Megacolon	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Nausea	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Pancreatitis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Retroperitoneal haematoma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Chest discomfort	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Chest pain	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Death	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Multiple organ dysfunction syndrome	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Non-cardiac chest pain	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Pyrexia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Vascular stent stenosis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
General disorders Vascular stent thrombosis	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Hepatobiliary disorders Cholecystitis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Hepatobiliary disorders Cholecystitis acute	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Bacterial infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Beta haemolytic streptococcal infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Bronchitis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Cellulitis	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Clostridium difficile colitis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Clostridium difficile infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Ear infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Escherichia infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Gastroenteritis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Gastroenteritis viral	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Haemophilus sepsis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Perineal abscess	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Pneumocystis jirovecii pneumonia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Pneumonia	1.1% 11/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Sepsis	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Septic shock	0.80% 8/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Staphylococcal infection	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Thrombophlebitis septic	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Urinary tract infection	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Infections and infestations Urosepsis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Anaemia postoperative	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Aneurysm recanalisation	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Brain herniation	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Face injury	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Hip fracture	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Incision site complication	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	1.3% 13/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Subdural haematoma	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Tracheostomy malfunction	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Urinary retention postoperative	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Vascular access site complication	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Investigations Blood pressure increased	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Investigations Neurological examinations abnormal	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Investigations Transaminases increased	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Metabolism and nutrition disorders Acidosis hyperchloraemic	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Metabolism and nutrition disorders Failure to thrive	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Metabolism and nutrition disorders Hypernatraemia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Metabolism and nutrition disorders Hyponatraemia	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Metabolism and nutrition disorders Lactic acidosis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Musculoskeletal and connective tissue disorders Back pain	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Musculoskeletal and connective tissue disorders Flank pain	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraganglion neoplasm	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Aphasia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Ataxia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Brain compression	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Brain oedema	0.80% 8/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Brain stem infarction	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Brain stem stroke	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Carotid artery aneurysm	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Carotid artery dissection	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral aneurysm perforation	0.60% 6/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral artery embolism	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral artery occlusion	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral artery thrombosis	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral congestion	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral haematoma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral haemorrhage	0.40% 4/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral infarction	0.70% 7/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral thrombosis	0.40% 4/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral vasoconstriction	1.4% 14/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral venous thrombosis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral ventricle dilatation	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebral spinal fluid leakage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Cerebrovascular accident	1.2% 12/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Dizziness	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Dural arteriovenous fistula	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Dysarthria	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Embolic stroke	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Encephalopathy	0.40% 4/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Haemorrhage intracranial	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Haemorrhagic stroke	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Headache	1.3% 13/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Hemiparesis	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Hydrocephalus	2.3% 23/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Hypertensive encephalopathy	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Hypoaesthesia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Intracranial aneurysm	0.40% 4/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Intracranial pressure increased	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Ischaemic cerebral infarction	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Ischaemic stroke	1.2% 12/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Migraine	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Neurological decompensation	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Partial seizures	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Phantom pain	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Ruptured cerebral aneurysm	0.60% 6/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Seizure	1.0% 10/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Seizure like phenomena	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Status epilepticus	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Subarachnoid hematoma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Syncope	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Transient global amnesia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Transient ischaemic attack	0.70% 7/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders VIth nerve paralysis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Vocal cord paralysis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Alcohol withdrawal syndrome	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Apathy	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Delirium	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Insomnia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Intentional self-injury	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Mental status changes	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Psychiatric disorders Psychogenic seizure	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Renal and urinary disorders Acute kidney injury	0.40% 4/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Renal and urinary disorders End stage renal disease	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Renal and urinary disorders Renal injury	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Renal and urinary disorders Urethral haemorrhage	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Renal and urinary disorders Urinary retention	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.70% 7/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Asthma	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.30% 3/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Pneumonia disorder	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.60% 6/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.60% 6/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary eodema	0.50% 5/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 17/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Respiratory, thoracic and mediastinal disorders Vocal cord disorder	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Skin and subcutaneous tissue disorders Rash	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Surgical and medical procedures Cerebral endovascular aneurysm repair	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Surgical and medical procedures Peripheral artery stent insertion	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Aneurysm	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Arteriovenous fistula	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Deep vein thrombosis	0.60% 6/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Embolism	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Hypotension	0.20% 2/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Intermittent claudication	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Labile blood pressure	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Orthostatic hypotension	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Peripheral artery thrombosis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Peripheral ischaemia	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Shock	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Shock haemorrhagic	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Vasospasm	1.0% 10/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Vascular disorders Venous stenosis	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Haemorrhagic cerebral infarction	0.10% 1/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.

Other adverse events

Measure	Penumbra Smart System n=995 participants at risk Penumbra Smart Coil Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD): Other Penumbra Coils available as standard of care
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	3.0% 30/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.
Nervous system disorders Nervous system disorders	6.5% 65/995 • 1 year Since this a post market registry, we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of consent through registry exit. If an AE occurs that is not related to the procedure or device, it is not reportable under this Protocol.

Additional Information

Director of Clinical Affairs

Penumbra, Inc.

Phone: +1 510 995 2183

Email: blawson@penumbrainc.com

Results disclosure agreements

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