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

Model Number PED-425-25

Device Problem Fracture (1260)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

As received the device for investigation, the pipeline flex pushwire was found separated proximal to the dps sleeves.This condition of the device was not reported initially.It was found the pipeline flex embolization device was returned within the marksman catheter.The pipeline flex pushwire was found protruding from within the marksman hub.The pipeline flex delivery system could not be pushed forward or pulled back from within the marksman as it appears to be locked up within the distal segment of the marksman.For further examination, the marksman catheter was dissected at several locations; however, only the distal end of the pipeline flex delivery system was able to be uncovered.The uncovered section of distal hypotube was found stretched with the ptfe shrink tubing still intact.However, the pipeline flex pushwire was found separated proximal to the dps sleeves.The pipeline flex braid was not returned and the dps sleeves with tip coil were found separated and not returned.The pipeline flex pushwire was sent out for scanning electron microscope (sem) failure analysis.Based on the device analysis, reported information and sem report, ¿the pushwire failed via torsional overload.¿ it is likely the pipeline flex pushwire separated as the user continued to retrieve the device against resistance.Related mdr for this event: 2029214-2019-00277.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that after the marksman microcatheter was in place, the pipeline flex was delivered, the large resistance occurred, the stent cannot be pushed out of the microcatheter.The patient underwent embolization treatment for a small unruptured saccular left internal carotid artery aneurysm, measuring 8mmx5mm, landing zone distal 3.95mm, proximal 4.20mm.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Evaluation of the returned device found that the pipeline flex pushwire was found separated proximal to the dps sleeves.

• 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 ; 7635263305
• MDR Report Key: 8749508
• MDR Text Key: 149680141
• Report Number: 2029214-2019-00653
• Device Sequence Number: 1
• Product Code: OUT
• 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: 07/01/2019

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: 10/16/2021
• Device Model Number: PED-425-25
• Device Lot Number: A725107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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: 60 YR