MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Therapeutic Effects, Unexpected (2099)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Dmytriw aa, phan k, salem mm, et al.The pipeline embolization device: changes in practice and reduction of complications in the treatment of anterior circulation aneurysms in a multicenter cohort.Neurosurgery.March 2019.Doi:10.1093/neuros/nyz059.Medtronic received a report from a clinical study through a literature article to assess aneurysm occlusion and complication rates over time.284 procedures took place for 321 anterior circulation aneurysms, in 251 female, 33 male patients.The study took place between 2011 and 2016, and the average aneurysm size was 6.7mm.Aneurysms were primarily located along the ica, pcom, aca/anterior communicating artery, and middle cerebral artery.Complete or near complete occlusion (>90%) was achieved in 85.9% of aneurysms.In total there were 9 acute subarachnoid hemorrhages, 26 remote.Endovascular retreatment occurred in 18 patients.23 thromboembolic events, 11 symptomatic, and 8 hemorrhagic events, 4 symptomatic occurred.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9233589
• MDR Text Key: 168708274
• Report Number: 2029214-2019-01066
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-RPT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR