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

Model Number	PED-500-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
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 while attempting to open the device, it would not open correctly in the distal section of the pipeline.It was stated it looked like a tulip.More than 50% of the pipeline had been deployed when it failed.It was resheathed less than or equal to 2 times.The pipeline was positioned in a distal part of a bend.No additional steps or other devices were required to open the pipeline.The pipeline was resheathed and removed with the microcatheter from the patient.Angiographic result post procedure was good.The patient was undergoing surgery to treat an unruptured, saccular aneurysm located at the opthalmic artery with a max diameter of 5mm and a neck diameter of 4mm.It was noted the vessel tortuosity was severe.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.

• 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: 10993291
• Report Number: 2029214-2020-01285
• Device Sequence Number: 3478151
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

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: 08/19/2021
• Device Model Number: PED-500-12
• Device Catalogue Number: PED-500-12
• Device Lot Number: A694934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR