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

Model Number	PED-425-20
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the pipeline flex embolization device and marksman catheter were returned for analysis within a shipping box and within a plastic bio-pouch.Visual inspection/damage location details: the pipeline flex embolization device was returned within the marksman catheter.The pi peline flex pusher was found extending from within the marksman catheter hub for ~67.2cm.The marksman catheter body was found stretched and accordioned from ~32.7cm to ~26.7cm from the catheter distal tip.No damage was found with the marksman distal tip.The pip eline flex embolization device could not be removed from within the marksman catheter as it was found stuck.The marksman catheter was dissected (cut) and the pipeline flex embolization device was removed.No bends or kinks were found with the pipeline flex pusher.However, the distal pusher with shrink tubing were found stretched.The pusher resheathing pad was found in good condition.However, the distal core wire was found broken between the resheathing pad and the sleeves.In addition, the distal core wire was found broken distal to the sleeves.The pusher sleeves were found in good condition.The sleeves distal restraint and tip coil outer coils were found to have detached from the distal core wire.Both ends of the pipeline flex braid were found damaged (frayed).Testing/analysis: both segments of the broken distal core wire were sent out for sem (scanning electron microscopy) failure analysis.Per the analysis report, both separated ends exhibited extensive corrosion damage.Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ and ¿catheter kink/damage¿ reports were confirmed.From the damages seen with the marksman catheter (accordioning) and the pipeline flex embolization device (pusher stretching) it appears force may have been used.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment, and re-sheathing of the device in distal and tortuous anatomies.It is likely the patient¿s ¿severe¿ vessel tortuosity contributed to the event.Regarding the separation of the distal core wire, the separation likely occurred upon return to medtronic for evaluation or during the device evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline was completely stuck and the resistance was large inside the catheter.No matter if the tension was increased or decreased, it could not be deployed forward or retracted.The pipeline and marksman catheter were withdrawn from the body as a whole and it was found that the marksman was partially deformed and the pipeline was completely stuck in the middle of the marksman.The catheter was damaged at the distal end, the damage was described as accordion.The pushwire was not damaged.The devices were prepared as indicated in the ifu.The catheter was flushed according to the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 6mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was severe.A dapt (dual antiplatelet) treatment was administered and the pru level was double antibody for 7 days.There were no patient symptoms or complications associated with the event.Ancillary devices include: a cook 6f, a 5f 115 navien, a marksman catheter, and a synchro14 guidewire.2021-12-24 e1 (for, rep, hcp): no additional information received.2022-jan-28 ared (for, rep): no new information.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13944194
• Report Number: 2029214-2022-00515
• Device Sequence Number: 6702186
• Product Code: OUT
• UDI-Device Identifier: 00847536016200
• UDI-Public: 00847536016200
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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: 06/08/2024
• Device Model Number: PED-425-20
• Device Catalogue Number: PED-425-20
• Device Lot Number: B218606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female