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

Model Number PED-425-20

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

Patient Problems Infarction, Cerebral (1771); Embolus (1830)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that post-op, the patient experienced an asymptomatic stroke/cerebral infarction, distal embolism at the target blood vessel area.The patient was undergoing surgery for treatment of a saccular, left c4 paraclinoid/parasellar aneurysm with a max diameter of 10.0 mm and a 6.8 mm neck diameter.It was reported that the patient experienced an asymptomatic stroke/cerebral infarction, distal embolism at the target blood vessel area.It was noted as not serious and the patient recovered with a confirmation date of (b)(6) 2018.Treatment included aspirin and c lopidogrel.A causal relationship with the equipment/procedure could not be denied.

• 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: 9616736
• MDR Text Key: 188885364
• Report Number: 2029214-2020-00062
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015487
• UDI-Public: 00836462015487
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2018
• Device Model Number: PED-425-20
• Device Catalogue Number: PED-425-20
• Device Lot Number: A067430
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• 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: 42 YR
• Patient Weight: 65