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

Model Number	PED-400-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Embolus (1830)
Date of Event	01/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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 side c3 cavernous sinus aneurysm.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) 2016.Treatment included aspirin and other antiplatelet drugs due to clopidogrel insensitivity syndrome.A causal relationship with the equipment/procedure could not be denied.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9616836
• Report Number: 2029214-2020-00063
• Device Sequence Number: 10909183
• Product Code: OUT
• UDI-Device Identifier: 00836462015814
• UDI-Public: 00836462015814
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2018
• Device Model Number: PED-400-35
• Device Catalogue Number: PED-400-35
• Device Lot Number: A069819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 44