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

Model Number	PED-475-30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reportable due to analysis findings.There was no pipeline flex braid returned with the pusher.The pipeline flex pusher was found outside of the marksman catheter.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The pipeline flex pusher appeared to be detached at the hypotube proximal to the wire weld with the tip coil, distal marker, re-sheathing marker and proximal bumper were not returned for analysis.The end of the detached pusher was sent out for sem/eds analysis.No other damages or anomalies were observed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the pipeline flex embolization device (ped) was stuck in the distal segment of the marksman micr ocatheter after approximately one third of the pipeline was deployed and it could not be released anymore.It was not possible to retrieve it also.The stent and microcatheter had to be retrieved as a whole.A new pipeline and marksman were used and the marksman was able to be in place, but the pipeline could not be in place.This new entire system was removed and the distal segment of the new marksman microcatheter was found to be accordioned.A third marksman was used to complete the surgery.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured amorphous aneurysm measuring 5.9mm x 12mm located in the posterior communicating artery.The distal and proximal landing zone was 3.69mm x 4.67mm.The vasculature was severe in tortuosity.The patient was on dual antiplatelet therapy (dapt), but pru level was unknown.Access was through the femoral artery with diameter of 8.8mm.The catheter was flushed with heparinized saline.The physician released the load (slack) in the system, but it did not resolve the problem.The proximal end of the pushwire was observed to be damaged(kinked).

• 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: 10368835
• Report Number: 2029214-2020-00771
• Device Sequence Number: 2865530
• Product Code: OUT
• UDI-Device Identifier: 00847536016804
• UDI-Public: 00847536016804
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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: 07/09/2022
• Device Model Number: PED-475-30
• Device Catalogue Number: PED-475-30
• Device Lot Number: A861605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 08/05/2020
• 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