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

Model Number	PED-450-20
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that resistance felt during delivered pipeline flex in the marksman catheter and after that distal end of the pipeline did not open.The patient was undergoing embolization treatment for a aneurysm with flow diversion.The vessel was observed moderately tortuous.Reported device and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.It was reported that during the operation, microcatheter was found to have great resistance during the delivery of the stent, and barely completed the release of pipeline flex.It was reported that the proximal end of the pipeline flex stent was not fully opened and not attached to the wall.A balloon was used to expand the pipeline device.There were no patient symptoms or complications associated with this event.

• 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: 8580857
• Report Number: 2029214-2019-00408
• Device Sequence Number: 19297868
• Product Code: OUT
• UDI-Device Identifier: 00847536016477
• UDI-Public: 00847536016477
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2019

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: 05/21/2021
• Device Model Number: PED-450-20
• Device Lot Number: A649249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/05/2019
• 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