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

Model Number PED-450-16

Device Problems Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2019

Event Type  malfunction  

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 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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9257929
• MDR Text Key: 168454374
• Report Number: 2029214-2019-01092
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016415
• UDI-Public: 00847536016415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR