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

Model Number PED-450-20

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

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

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex embolization device (with shield technology) was returned for analysis.No bends or kinks were found with the pipeline flex pusher.The pipeline flex distal hypotube was found stretched.No breaks or separations were found with the hypotube.The ptfe shrink tubing was intact but pulled back from the proximal bumper.The hypotube proximal to the wire weld was found intact.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The pipeline flex distal pushwire was found separated proximal to dps restraints/sleeves.The dps restraints/sleeves with tip coil and braid were found missing.The pipeline flex braid ends were found fully open but damaged (frayed).The separated pushwire end was sent out for sem failure analysis.Per the sem report, the wire failed via torsional overload.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete to open at middle section¿ could not be confirmed as the pipeline flex braid was found fully open.The most likely cause was determined to be use context as the braid was deployed in a vessel bend.In addition, as the patient vessel tortuosity was ¿severe¿ it is possible the braid was overstretched during delivery contributing to the ¿failure/incomplete to open¿ issue.Regarding the customer¿s report of ¿distal tip separation¿ the issue was confirmed as the pipeline flex distal pushwire was found separated.Pushwire separation can be caused by patient vessel tortuosity, resistance of delivery wire during delivery/retrieval, over-manipulation, or user resheaths more than 2 times.From the damages seen with the pipeline flex pusher (hypotube stretching/pushwire break); it appears there was high force used.The device involved in this event is not approved in the us; the device's brand name and model number are provided below.This report is being filed against a similar device, which is provided.Brand name: pipeline flex with shield technology, model number: ped2-450-20.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex with shield distal tip separation.The patient was undergoing treatment of an unruptured, fusiform aneurysm in the left carotid-ophthalmic.The aneurysm max.Diameter was 8mm and neck was 1.5mm.Vessel tortuosity was described as severe.The devices were prepared as indicated in the ifu and a continuous flush was maintained.It was reported that during the procedure, the pipeline flex with shield was advanced and deployed out of a catheter.There was reportedly no resistance.The device opened distally without any issue.It was noted that the device had been deployed on a vessel curve and appeared to be "elongated and not completely open, like a string." the device was resheathed and re-deployed several times without resolving the issue.After a push-pull maneuver, the physician chose to remove the device from the patient.Outside of the patient, the pipeline flex with shield was examined.It was noted that the distal tip of the pipeline had "broke and separated by the pushwire." 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: 9837464
• MDR Text Key: 184452325
• Report Number: 2029214-2020-00239
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/16/2020

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: 11/25/2022
• Device Model Number: PED-450-20
• Device Lot Number: A938294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Date Device Manufactured: 11/26/2019
• 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: 46 YR
• Patient Weight: 64