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

Model Number	PED-450-25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the pipeline flex was completely released.During the process of retrieving the guidewire, the guidewire was broken when the microcatheter and the guidewire passed through the middle part of the stent, leaving the protection coil inside the body.Then the operator captured the guide wire and the protection coil with solitaire and took it out.No patient injury occurred.The devices were prepared and used per the instructions for use (ifu).No friction or difficulty was experienced.This event occurred during the treatment of a cavernous sinus, unruptured aneurysm.The max diameter was 9mm and the neck was 4mm.The distal landing zone was 4.1mm and the proximal was 4.5mm.The vessel anatomy was normal in tortuosity.

• 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: 9553269
• Report Number: 2029214-2020-00006
• Device Sequence Number: 2082024
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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: 06/14/2022
• Device Model Number: PED-450-25
• Device Lot Number: A848747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR