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

Model Number PED-475-10

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

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.Linked with mdr: 2029214-2020-00032, 2029214-2020-00033.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the patient was reported to have been treated for a post traumatic automobile accident that resulted in a left, proximal, internal carotid artery (ica) pseudoaneurysm /fistula.The patient was initially treated with 2 flow diverter.However, since the blood flow was still present the patient underwent a second pipeline procedure on (b)(6) 2019 and a 3rd pipeline was implanted.

• Brand Name: PIPELINE FLEX
• 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: 9580332
• MDR Text Key: 174895005
• Report Number: 2029214-2020-00034
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016590
• UDI-Public: 00847536016590
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Model Number: PED-475-10
• Device Lot Number: A724442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2018
• 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: 41 YR