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

Model Number	PED-450-16
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex was returned as part of this investigation.Analysis found the distal tip coil appeared to be damaged.The distal hypotube appeared to be stretched.The outer jacket on the distal hyotube appeared to be damaged and pulled back approximately 2.5cm from the broken end.The pipeline flex pushwire found to be separated at the distal hypotube.Bends observed on the pusher approximately 42 to 61cm from the proximal end.The dimple features on the surface of the broken end are consistent with overload failure.From the damages seen on the catheter body (flattening/accordioning), pipeline flex pusher (bending), pipeline flex braid (fraying) and hypotube (stretching and separating); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex through the phenom catheter against resistance.It is likely that the severe vessel tortuosity may contribute to the resistance during delivery/retrieval; subsequently causing the pushwire to separate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of pipeline flex pushwire separation.The patient was undergoing treatment of an unruptured aneurysm.Vessel tortuosity was described as severe.The devices were prepared as indicated in the ifu.A continuous flush was maintained.It was reported that during the procedure, the pipeline flex was deployed.The microcatheter was advanced back through the pipeline flex device to capture the delivery wire.There was strain pulling on the delivery wire back into the catheter.Upon conducting a run, it was noticed that the pipeline flex pushwire broke at the proximal bumper.Aspiration was started the system was removed.The broken piece was removed.There were no reports of patient injury in association 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: 9257929
• Report Number: 2029214-2019-01092
• Device Sequence Number: 16657818
• Product Code: OUT
• UDI-Device Identifier: 00847536016415
• UDI-Public: 00847536016415
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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: 09/10/2022
• Device Model Number: PED-450-16
• Device Lot Number: A896154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR