Trial Outcomes & Findings for Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study (NCT NCT02378883)

NCT ID: NCT02378883

Last Updated: 2019-04-29

Results Overview

Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 112 participants
• Primary outcome timeframe: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
• Results posted on: 2019-04-29

Participant Flow

Participant milestones

Measure	APOLLO The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Enrollment STARTED	121
Enrollment COMPLETED	112
Enrollment NOT COMPLETED	9
Discharge STARTED	112
Discharge COMPLETED	112
Discharge NOT COMPLETED	0
30 Day Follow-Up STARTED	112
30 Day Follow-Up COMPLETED	106
30 Day Follow-Up NOT COMPLETED	6
12 Months Follow-Up STARTED	46
12 Months Follow-Up COMPLETED	41
12 Months Follow-Up NOT COMPLETED	5

Reasons for withdrawal

Measure	APOLLO The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Enrollment Subject did not meet Inclusion criteria	6
Enrollment Attempt to use Apollo was not performed	3
30 Day Follow-Up Withdrawal by Subject	1
30 Day Follow-Up Physician Decision	2
30 Day Follow-Up Missed Visit	2
30 Day Follow-Up Death	1
12 Months Follow-Up Lost to Follow-up	3
12 Months Follow-Up Death	2

Baseline Characteristics

Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study

Baseline characteristics by cohort

Measure	APOLLO n=112 Participants The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Age, Continuous	44.1 years STANDARD_DEVIATION 17.6 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants
Smoking Never smoked or not smoked within last 10 yrs	54 Participants n=5 Participants
Smoking Not a current smoker but has smoked in past 10 yrs	23 Participants n=5 Participants
Smoking Current smoker, less than one pack per day	19 Participants n=5 Participants
Smoking Current smoker more than or equal to one pack/day	13 Participants n=5 Participants
Smoking Unknown	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Population: The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.

Premature (unintentional) catheter tip detachment with clinical sequelae

Catheter rupture/break/fracture with clinical sequelae

Retained catheter body in the vasculature

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Catheter-related Adverse Events at 30 Days	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Rate of premature (unintentional) catheter tip detachment

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Rate of intentional catheter tip detachment

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Intentional Catheter Tip Detachment at 30 Days	68 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Rate of migration of the retained catheter tip post embolization

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Rate of catheter/tip leakage from detachment zone

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Incidence of catheter-related adverse events at 30 days

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Catheter-related Adverse Events at 30 Days	31 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Catheter-related Adverse Events at 12 Months	68 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter

Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)

Outcome measures

Measure	AVM Treatment n=112 Participants Apollo™ Onyx™ Delivery Microcatheter
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months	0 Participants

Adverse Events

APOLLO

Serious events: 39 serious events

Other events: 51 other events

Deaths: 3 deaths

Serious adverse events

Measure	APOLLO n=112 participants at risk The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Blood and lymphatic system disorders Thrombocytopenia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Gastrointestinal disorders Constipation	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Gastrointestinal disorders Vomiting	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Infections and infestations Brain abscess	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Infections and infestations Pneumonia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Infections and infestations Postoperative wound infection	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Infections and infestations Urosepsis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Procedural haemorrhage	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Subarachnoid haemorrhage	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Subdural haemorrhage	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Vascular injury	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Wound dehiscence	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Metabolism and nutrition disorders Electrolyte imbalance	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Aphasia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Brain oedema	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebral haemorrhage	3.6% 4/112 • Number of events 4 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebrospinal fluid leakage	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Encephalopathy	2.7% 3/112 • Number of events 3 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Haemorrhage intracranial	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Haemorrhagic stroke	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Hemianopia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Hemiparesis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Hydrocephalus	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Intracranial pressure increased	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Intraventricular haemorrhage	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Ischaemic stroke	5.4% 6/112 • Number of events 6 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Migraine	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Monoparesis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Neuropathy peripheral	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Seizure	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Syncope	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Psychiatric disorders Alcohol withdrawal syndrome	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Psychiatric disorders Hallucination	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Air embolism	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Deep vein thrombosis	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Vessel perforation	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)

Other adverse events

Measure	APOLLO n=112 participants at risk The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.
Injury, poisoning and procedural complications Vascular access site haematoma	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Cardiac disorders Bradycardia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Eye disorders Diplopia	3.6% 4/112 • Number of events 4 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Eye disorders Photophobia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Eye disorders Vision blurred	3.6% 4/112 • Number of events 4 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Eye disorders Visual impairment	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Gastrointestinal disorders Constipation	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Gastrointestinal disorders Nausea	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Gastrointestinal disorders Vomiting	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
General disorders Adverse drug reaction	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
General disorders Chest Pain	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
General disorders Fatigue	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Infections and infestations Pneumonia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Infections and infestations Urinary tract infection	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Pneumocephalus	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Pseudomeningocele	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Subarachnoid haemorrhage	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Subdural haematoma	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Injury, poisoning and procedural complications Vascular access site haemorrhage	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Metabolism and nutrition disorders Hypokalaemia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Metabolism and nutrition disorders Hypomagnesaemia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Metabolism and nutrition disorders Hypophosphataemia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Brain oedema	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebral artery thrombosis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebral haemorrhage	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebral infarction	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebral vasoconstriction	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Cerebrovascular accident	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Dizziness	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Dysmetria	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Facial paralysis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Haemorrhage intracranial	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Headache	15.2% 17/112 • Number of events 18 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Hemianopia homonymous	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Hypoaesthesia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Ischaemic stroke	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Paraesthesia	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Quadrantanopia	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Seizure	7.1% 8/112 • Number of events 9 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Nervous system disorders Vertebral artery dissection	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Renal and urinary disorders Haematuria	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Deep vein thrombosis	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Hypotension	1.8% 2/112 • Number of events 2 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Thrombophlebitis superficial	0.89% 1/112 • Number of events 1 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)
Vascular disorders Vasospasm	7.1% 8/112 • Number of events 11 • Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months) The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Serious Adverse Events (SAEs) * All device-related Adverse Events * All procedure-related Adverse Events * All AEs with an underlying neurological cause (neurological adverse event)

Additional Information

Darren Lacour, Sr. Manager, Clinical Project Management

Medtronic Neurovascular

Phone: 949-680-1274

Email: darren.j.lacour@medtronic.com

Results disclosure agreements

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