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

Model Number FA-71475-25

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

Patient Problem Stenosis (2263)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.Wu h, wang m, li k, wang f.Treatment of extracranial vertebral artery aneurysm with flow diversion.World neurosurg.2020;138:328-331.Doi:10.1016/j.Wneu.2020.03.064.If information is provided in the future, a supplemental report will be issued.

Event Description

Wu h, wang m, li k, wang f.Treatment of extracranial vertebral artery aneurysm with flow diversion.World neurosurg.2020;138:328-331.Doi:10.1016/j.Wneu.2020.03.064.Medtronic literature found reported of patient complications in association with a pipeline embolization device.The purpose of this article was to treat a (b)(6) woman, which computed tomography angiography demonstrated a right extracranial vertebral artery aneurysm.The saccular aneurysm (7.9 3 6.6 mm) was demonstrated on digital subtraction angiography at the v3 segment of the right vertebral artery.A pipeline embolization device was placed in the diseased parent artery.The patency of the pipeline embolization device was confirmed at 12-month follow-up.This article does not state any technical issues during the use of the pipeline.The following intra- or post-procedural outcomes were noted: case 1: moderate in-stent stenosis was observed at 3-month follow up.The anti-platelet therapy was prolonged with aspirin and clopidogrel for another year.At the 12-month follow-up, there was no progression of the in stent stenosis.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10325906
• MDR Text Key: 203823550
• Report Number: 2029214-2020-00732
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA-71475-25
• Device Catalogue Number: FA-71475-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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): Required Intervention
• Patient Age: 72 YR