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

Model Number PED-475-25

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

Patient Problems Death (1802); Rupture (2208)

Event Date 05/01/2019

Event Type  Death  

Manufacturer Narrative

Date of death is approximate.Event date approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient underwent a procedure for a left-sided pipeline stent.Eight days later, the patient collapsed at home and was found to have a rupture of the left aneurysm.The following day, the patient passed away.It was stated the device malfunctioned and was clarified to mean the device did not do what it was supposed to do.The patient was undergoing surgery for treatment of a large, left oa aneurysm.

• 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: 9678490
• MDR Text Key: 178095369
• Report Number: 2029214-2020-00106
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016774
• UDI-Public: 00847536016774
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: A612922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/06/2020
• Date Device Manufactured: 03/14/2018
• 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): Death
• Patient Age: 44 YR