Trial Outcomes & Findings for Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (NCT NCT01716117)

NCT ID: NCT01716117

Last Updated: 2022-12-19

Results Overview

Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 213 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-12-19

Participant Flow

Participant milestones

Measure	Surpass Flow Diverter (mITT Population) The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Surpass Flow Diverter (Roll-In Population) An additional 45 "Roll-In" subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 "Roll-In" and "Enrolled but Not Treated" subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes.
Overall Study STARTED	180	33
Overall Study Discharge	177	33
Overall Study 1-Month Visit	176	33
Overall Study 6-Month Visit	174	32
Overall Study COMPLETED	173	31
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Measure	Surpass Flow Diverter (mITT Population) The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Surpass Flow Diverter (Roll-In Population) An additional 45 "Roll-In" subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 "Roll-In" and "Enrolled but Not Treated" subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes.
Overall Study Death	5	2
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms

Baseline characteristics by cohort

Measure	Surpass Flow Diverter (mITT) n=180 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Roll-In n=33 Participants An additional 45 "Roll-In" subjects were permitted in the original approved clinical protocol, which was updated to allow for up to 70 "Roll-In" and "Enrolled but Not Treated" subjects. Data from this population were not included in the mITT Primary Endpoint analysis. Neither did they serve as a control population. Results are displayed for informational purposes.	Total n=213 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 9.9 • n=93 Participants	62.4 years STANDARD_DEVIATION 11.1 • n=4 Participants	61.2 years STANDARD_DEVIATION 10.1 • n=27 Participants
Sex: Female, Male Female	165 Participants n=93 Participants	29 Participants n=4 Participants	194 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	4 Participants n=4 Participants	19 Participants n=27 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Asian	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	26 Participants n=93 Participants	7 Participants n=4 Participants	33 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized White	140 Participants n=93 Participants	22 Participants n=4 Participants	162 Participants n=27 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Not Reported	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	14 Participants n=93 Participants	4 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	158 Participants n=93 Participants	29 Participants n=4 Participants	187 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	6 Participants n=93 Participants	0 Participants n=4 Participants	6 Participants n=27 Participants
Age	61.5 years n=93 Participants	65.0 years n=4 Participants	62.0 years n=27 Participants
Height	65.0 inches (in) n=93 Participants	64.2 inches (in) n=4 Participants	65.0 inches (in) n=27 Participants
Weight	158.4 pounds (lbs) n=93 Participants	149.6 pounds (lbs) n=4 Participants	158.4 pounds (lbs) n=27 Participants
Body Mass Index (BMI)	27.0 lbs/in^2 n=93 Participants	26.0 lbs/in^2 n=4 Participants	27.0 lbs/in^2 n=27 Participants
Smoking Status/Alcohol Use Current Smoker	36 Participants n=93 Participants	10 Participants n=4 Participants	46 Participants n=27 Participants
Smoking Status/Alcohol Use Past Smoker	79 Participants n=93 Participants	11 Participants n=4 Participants	90 Participants n=27 Participants
Smoking Status/Alcohol Use Current Consumer of Alcohol	91 Participants n=93 Participants	12 Participants n=4 Participants	103 Participants n=27 Participants

PRIMARY outcome

Timeframe: 12 months

Population: The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in population (n = 33).

Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=180 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months Subgroups of patients who had full apposition of the device to the vessel wall.
mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit. Retreatment of Target Intracranial Aneurysm	0.6 Percent of participants Interval 0.0 to 3.1	—
mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit. Primary Effectiveness Endpoint Composite Success	62.8 Percent of participants Interval 55.3 to 69.9	—
mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit. Parent Artery Stenosis > 50%	3.3 Percent of participants Interval 1.2 to 7.1	—

PRIMARY outcome

Timeframe: 12 months

Population: The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in arm (n = 33).

Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=180 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months Subgroups of patients who had full apposition of the device to the vessel wall.
mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. Major Ipsilateral Stroke	19 Participants	—
mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. Neurological Death	5 Participants	—
mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up. Primary Safety Endpoint Failure	19 Participants	—

SECONDARY outcome

Timeframe: 12 months

Population: mITT population

The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=34 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months n=125 Participants Subgroups of patients who had full apposition of the device to the vessel wall.
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure Raymond-Roy III	14 Participants	12 Participants
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure Raymond-Roy I	17 Participants	99 Participants
Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure Raymond-Roy II	3 Participants	14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: Secondary endpoint analysis of the mITT population (n = 180) are presented herein for comparison to results of subjects in the Roll-in population (n = 33).

Patients with minor strokes through 12 months

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=180 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months n=33 Participants Subgroups of patients who had full apposition of the device to the vessel wall.
Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up	12 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: mITT population

Primary effectiveness by age group

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=114 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months n=66 Participants Subgroups of patients who had full apposition of the device to the vessel wall.
Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population	80 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Population: mITT Population

Primary effectiveness by intracranial aneurysm size

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=167 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months n=13 Participants Subgroups of patients who had full apposition of the device to the vessel wall.
CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population	107 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 Months

Number of devices implanted in subjects by study population

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=180 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months n=33 Participants Subgroups of patients who had full apposition of the device to the vessel wall.
Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations None	3 Participants	0 Participants
Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations One	156 Participants	25 Participants
Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations Two	21 Participants	7 Participants
Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations >2	0 Participants	1 Participants

POST_HOC outcome

Timeframe: 12 Months

Population: mITT Population

Subjects experiencing neurologic death or disabling stroke through 12 months.

Outcome measures

Measure	Surpass Flow Diverter (mITT Population) n=180 Participants The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Device Fully Apposed to Vessel Wall at 12 Months Subgroups of patients who had full apposition of the device to the vessel wall.
Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up Disabling Stroke or Neurologic Death	6.1 Percent of participants Interval 3.1 to 10.7	—
Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up Neurologic Death	2.8 Percent of participants Interval 0.9 to 6.4	—
Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up Disabling Stroke	6.1 Percent of participants Interval 3.1 to 10.7	—

Adverse Events

Surpass Flow Diverter (mITT Population)

Serious events: 54 serious events

Other events: 129 other events

Deaths: 5 deaths

Surpass Flow Diverter (Roll-in Population)

Serious events: 17 serious events

Other events: 24 other events

Deaths: 2 deaths

Serious adverse events

Measure	Surpass Flow Diverter (mITT Population) n=180 participants at risk The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Surpass Flow Diverter (Roll-in Population) n=33 participants at risk The Roll-in population was defined in the clinical protocol as all subjects who were enrolled as training cases and not considered part of the mITT population, and in whom the Surpass™ Flow Diverter entered the body regardless of whether or not the device was successfully implanted.
Blood and lymphatic system disorders Anemia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Atrial Fibrillation	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Diplopia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Retinal Artery Occlusion	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Retinal Infarction	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Visual Impairment	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Gastrointestinal Hemorrhage	2.8% 5/180 • Number of events 5 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Hematochezia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Retroperitoneal Hematoma	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Chest Pain	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Thrombosis in Device	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Infections and infestations Pneumonia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Vascular Pseudo-Aneurysm	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Metabolism and nutrition disorders Hyponatremia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	9.1% 3/33 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Amnesia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Carotid Artery Occlusion	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Dizziness	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Embolic Stroke	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Headache	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	15.2% 5/33 • Number of events 5 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Hemiparesis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Hemorrhagic Stroke	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Hydrocephalus	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Ischemic Stroke	6.1% 11/180 • Number of events 11 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	9.1% 3/33 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Subarachnoid Hemorrhage	2.8% 5/180 • Number of events 5 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Syncope	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Transient Ischemic Attack	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Confusional State	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Mental Status Changes	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Surgical and medical procedures Intra-Cerebral Aneurysm Operation	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Deep Vein Thrombosis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Embolism	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hematoma	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hemorrhage	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hypertension	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Anginia Pectoris	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Cardiac Failure Congestive	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Myocardial Infarction	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Optic Ischaemic Neuropathy	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Papilloedema	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Visual Acuity Reduced	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Infusion Site Extravasation	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Non-Cardiac Chest Pain	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Pseudocyst	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Concussion	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Hip Fracture	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Optic Nerve Injury	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Overdose	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Subdural Haematoma	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Wrist Fracture	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Convulsion	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Haemorrhage Intracranial	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders VIth Nerve Paralysis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Catatonia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Renal and urinary disorders Renal Failure	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Renal and urinary disorders Renal Mass	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Asthma	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Surgical and medical procedures Aneurysm Repair	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Aortic Aneurysm	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Arterial Stenosis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Thrombotic Stroke	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Metabolism and nutrition disorders Cerebral Salt-Wasting Syndrome	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Mental Status Changes Postoperative	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Infections and infestations Sepsis	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Device Occlusion	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Blindness	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.

Other adverse events

Measure	Surpass Flow Diverter (mITT Population) n=180 participants at risk The mITT population was defined in the clinical protocol as all enrolled subjects for whom the investigational device entered the body, regardless of whether or not the device was successfully implanted.	Surpass Flow Diverter (Roll-in Population) n=33 participants at risk The Roll-in population was defined in the clinical protocol as all subjects who were enrolled as training cases and not considered part of the mITT population, and in whom the Surpass™ Flow Diverter entered the body regardless of whether or not the device was successfully implanted.
Blood and lymphatic system disorders Anemia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	9.1% 3/33 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Arrhythmia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Atrial Fibrillation	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Cardiac disorders Cardiac Arrest	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Ear and labyrinth disorders Tinnitus	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Ear and labyrinth disorders Ear Pain	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Visual Impairment	7.8% 14/180 • Number of events 14 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	12.1% 4/33 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Diplopia	3.9% 7/180 • Number of events 7 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Eye Pain	4.4% 8/180 • Number of events 8 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Vision Blurred	3.9% 7/180 • Number of events 7 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Blepharitis	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Cataract	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Dry Eye	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Eye Pruritis	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Photophobia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Retinal Artery Occlusion	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Retinal Hemorrhage	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Nausea	5.6% 10/180 • Number of events 10 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	21.2% 7/33 • Number of events 7 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Constipation	3.3% 6/180 • Number of events 6 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Vomiting	3.3% 6/180 • Number of events 6 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	9.1% 3/33 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Dysphagia	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Mouth Hemorrhage	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Rectal Hemorrhage	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Abdominal Pain	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Dyspepsia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Hematochezia	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Gastrointestinal disorders Retroperitoneal Hematoma	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Fatigue	5.6% 10/180 • Number of events 10 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Thrombosis in Device	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Catheter Site Hemorrhage	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Chest Pain	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Oedema Peripheral	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Gait Disturbance	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
General disorders Implant Site Pain	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Infections and infestations Urinary Tract Infection	5.6% 10/180 • Number of events 10 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	12.1% 4/33 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Infections and infestations Pneumonia	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Infections and infestations Sinusitis	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Infections and infestations Bronchitis	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Contusion	5.0% 9/180 • Number of events 9 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Fall	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Traumatic Hematoma	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Vascular Injury	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Injury, poisoning and procedural complications Vascular Pseudo-Aneurysm	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Investigations Neurological Examination Abnormal	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Investigations Carotid Bruit	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Metabolism and nutrition disorders Hyponatremia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Metabolism and nutrition disorders Decreased Appetite	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Pain in Extremity	3.3% 6/180 • Number of events 6 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Back Pain	3.3% 6/180 • Number of events 6 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Neck Pain	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Groin Pain	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Muscular Weakness	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Dizziness	6.7% 12/180 • Number of events 12 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Reversible Ischemic Neurological Deficit	6.7% 12/180 • Number of events 12 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Hypoesthesia	3.9% 7/180 • Number of events 7 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Transient Ischemic Attack	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Amnesia	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Embolic Stroke	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Memory Impairment	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Migraine	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Aphasia	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Presyncope	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Ataxia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Carotid Artery Occlusion	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Hemiparesis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Hydrocephalus	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Third Nerve Paralysis	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Paresthesia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Restless Leg Syndrome	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Tremor	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Anxiety	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Confusional State	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Depression	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Insomnia	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Psychiatric disorders Mental Status Changes	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Renal and urinary disorders Urinary Retention	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.8% 5/180 • Number of events 5 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Cough	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Sleep Apnea Syndrome	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Skin and subcutaneous tissue disorders Ecchymosis	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Skin and subcutaneous tissue disorders Rash	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hypotension	5.6% 10/180 • Number of events 10 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hematoma	3.9% 7/180 • Number of events 7 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Vasospasm	3.3% 6/180 • Number of events 6 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hemorrhage	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	3.0% 1/33 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Hypertension	2.2% 4/180 • Number of events 4 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	9.1% 3/33 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Deep Vein Thrombosis	0.56% 1/180 • Number of events 1 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Vascular disorders Orithostatic Hypotension	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Vitreous Floaters	1.7% 3/180 • Number of events 3 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.1% 2/180 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	0.00% 0/33 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Nervous system disorders Headache	28.9% 52/180 • Number of events 52 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	42.4% 14/33 • Number of events 14 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Eye disorders Pupils Unequal	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/180 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.	6.1% 2/33 • Number of events 2 • Through 12 Months Post Procedure The definition of adverse event and/or serious adverse event used during the collection of adverse event information was consistent with that listed above in the clinicaltrials.gov definitions. Adverse events and serious adverse events were organized by System/Organ Class and Preferred Term.

Additional Information

Scott Courts, Clinical Program Manager

Stryker Neurovascular

Phone: 5104132170

Email: scott.courts@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research parties agree not to make any publication of study results, including without limitation the study data, until completion of the study and publication of the multi-center results in a peer-reviewed journal. Thereafter, the research parties may publish their individual site experience.
• Publication restrictions are in place

Restriction type: OTHER