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

Model Number	PED-450-25
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the first pipeline was deployed successfully; however with the same microcatheter, the second pipeline could not be opened well at the contralateral aneurysm, but it was still used.It was stated that there was catheter resistance in the distal section of the microcatheter.It was indicated that there was patient injury details of an aneurysm; however, the patient was being treated for a cerebral vascular aneurysm.The access vessel was the internal carotid artery ophthalmic artery segment, and its vessel diameter was 4.24mm.It was noted the vessel tortuosity was moderate.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Anxillary device: 6f 115cm navien guide catheter, marksman microcatheter.

• 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: 11755684
• Report Number: 2029214-2021-00518
• Device Sequence Number: 19714717
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: B125897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR