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

Model Number PED-450-20

Device Problems Break (1069); Unintended Ejection (1234); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The event was reported in lieu of analysis results.Analysis of the pipeline flex embolization device (lot no.B042477) found no bends or kinks with the pipeline flex pusher.The pipeline flex distal hypotube was found stretched with the ptfe shrink tubing pulled back from the proximal bumper.The pusher proximal bumper was found intact.The pusher resheathing pad was found damaged.The pusher distal core wire was found broken.The phenom 27 catheter was examined.The pipeline flex braid was found within the phenom 27 catheter hub.No damage was found with the phenom 27 catheter hub, catheter body, or distal tip.The phenom 27 catheter body was dissected (cut) and the pipeline flex braid and separated pusher distal segment was removed.The pipeline flex distal core wire was found to have broken proximal to the proximal sleeve restraint.The pusher ptfe sleeves and tip coil were found in good condition.The pipeline flex braid ends were found fully open.The braid proximal end was found damaged (frayed); however, the braid distal end was found in good condition.The broken core wire was sent out for sem (scanning electron micrographic) analysis.Per the analysis report, the distal core wire failed via torsional overload.Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.Regarding the customer¿s report of ¿device opens prematurely¿ was confirmed as the braid was found deployed in the phenom 27 catheter hub.Possible causes of failure include resistance during delivery, over-manipulation, pusher was torqued/pulled back during insertion or advancing inside catheter, or user resheaths the device more than two times.Regarding the pusher separation, separation can occur due to certain use conditions such as excessive force or patient vessel tortuosity.From the damages seen on the pipeline flex pusher (stretching) it appears excessive force may have been used.It is likely the reported resistance during delivery, torquing of the pusher as evident by the torsional overload failure of the core wire, and the patient¿s ¿moderate¿ vessel tortuosity contributed to the events.No defect was found with the returned phenom 27 catheter that would have contributed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline experienced resistance in the phenom 27 microcatheter and was found to be opened prematurely.The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the ophthalmic artery segment.The max diameter was 4mm, and the neck diameter was 2mm.The patient's vessel tortuosity was moderate.The landing zone was 4mm distal and 4.46mm proximal.The access vessel was the femoral artery, which was 8mm in diameter.It was reported that when the pipeline was pushed into the phenom 27 it encountered resistance in the distal segment.When the pipeline was withdrawn, the pipeline was unloaded from the push guide wire. the patient did not experience any injury or complications, and angiographic results post procedure were said to be good.The devices were prepared and flushed according to the instructions for use (ifu).

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12214925
• MDR Text Key: 263431520
• Report Number: 2029214-2021-00908
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016477
• UDI-Public: 00847536016477
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: B042477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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: 56 YR