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

Model Number	PED-425-35
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex device was returned for analysis.The hypotube was found stretched with the ptfe shrink tubing found intact.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The distal wire was found broken between the resheathing pad and the ptfe dps sleeves.The distal segment was not returned for analysis.Both braid ends were found fully opened, damaged, and frayed.The pipeline flex device could not be used for resistance testing as the braid was already deployed.The separated distal wire was sent out for sem testing.Based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ was confirmed.The hypotube was found stretched and the distal wire was found broken, indicative of retracting the device against resistance.Sem results of broken distal wire: ¿the wire failed via tortional overload.¿ this issue is similar to a previous investigation.Possible causes for resistance are damaged catheter, damages to the pushwire, damages to the braid, patient vessel tortuosity, user does not maintain continuous flush, or user pulls back on/ torques wire while advancing ped in micro catheter.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braids were returned already deployed and out of its protective introducer sheaths and dispenser coils.Customer reported all devices were prepared per ifu, aneurism was located in a bend, and patient vessel tortuosity as moderate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the catheter was delivered to the target location.The ped-425-35 was planned to be used, however, it could not be pushed out of the catheter after many attempts.The entire system was withdrawn, and another treatment option was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed aneurysm occlusion.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus segment with a max diameter of 15 mm and a 10 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was not available.Additional information was received.The catheter used was a marksman.There was resistance in the distal end of the catheter.The target aneurysm was located in a vessel bend.

• 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: 12972015
• Report Number: 2029214-2021-01585
• Device Sequence Number: 4573009
• Product Code: OUT
• UDI-Device Identifier: 00847536016293
• UDI-Public: 00847536016293
• 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): 12/09/2021

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: 01/13/2024
• Device Model Number: PED-425-35
• Device Catalogue Number: PED-425-35
• Device Lot Number: B144870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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 Sex: Unknown