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

Model Number	PED-500-12
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
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
Medtronic received a report that the pipeline failed to open proximally, and became hung up with the phenom 27 microcatheter resulting in a loss of vessel access.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery with a max diameter of 23 mm and a 10 mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that the first pipeline and coiling were deployed with no issues.When the second pipeline was deployed, it did not open proximally.During recapturing of the tip coil, the proximal braid may have been bumped with the phenom 27 microcatheter, because the pipeline became hung up and simultaneously pulled the wire, causing the physician to lose access.The healthcare provider (hcp) examined coming from the left side, but the patient did not have an anterior communicating (acom) artery, and so the hcp had to sacrifice the right internal carotid artery.It was noted the patient did wake up okay from the procedure.It was noted more than 50% of the pipeline had been deployed when it failed to open, it was "resheathed" less than or equal to two times, a wire/catheter was used to try and open the pipeline, full wall apposition was not achieved, ballooning was required for tapering or to ensure wall apposition.Post-procedure angiographic results showed the second pipeline seemed like it was relaxing proximally but still fairly tapered; stagnation in aneurysm.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a phenom 27 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: 9785613
• Report Number: 2029214-2020-00193
• Device Sequence Number: 19405361
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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: 08/30/2020
• Device Model Number: PED-500-12
• Device Catalogue Number: PED-500-12
• Device Lot Number: A517520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1