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

Model Number PED2-500-35

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

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

Event Date 12/23/2019

Event Type  malfunction  

Manufacturer Narrative

This is a report for a similar device that is not marketed in the us.Suspect medical device - similar device brand name = pipeline flex w/shield technology model # = ped2-500-35 as the device was received in a condition was contradictory to the complaint description.The pipeline flex device pushwire found broken.This condition was not reported at time of the event.The pipeline flex braid was returned detached from the pushwire.One end of the pipeline flex braid was found damaged (frayed) and not found fully open.The other end of the pipeline flex braid was found open and in good condition.As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified.The pipeline flex distal hypotube does not appear to be stretched and the ptfe shrink tubing was intact; however, the shrink tubing was found pulled back from the proximal bumper.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil outer coils were found stretched and broken with the inner core wire broken.The broken segment was sent to sem (scanning electron micrographic) for analysis.Per sem report, ¿few original fracture features were available to determine the wire failure mechanism.¿ based on the device evaluation we were unable to determined the cause of the event.The pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.In this event the cause was determined to be use related (excessive force) as ¿the pushwire was retrieved into the marksman with a strong force¿ related mdr for event: 2029214-2020-00038.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a third pipeline (reported device) was prepared and delivered in the medtronic catheter who had delivered to distal part, but the delivery became very difficult in the middle of the medtronic catheter.Eventually it became so hard, and it was impossible to deliver the device to the distal part of the catheter.Anomaly was felt, and the pipeline was retrieved together with the pushwire.The aneurysm was in the left internal carotid.It was unruptured and saccular.The max diameter was 15mm and the neck was 10mm.The distal landing zone was 3.06mm and the proximal was 5mm.The vessel anatomy was moderate in tortuosity.The devices were all reported to have been used and prepared per the instructions for use.A continuous flush was used.Evaluation of the returned device found that the pipeline flex shield braid was returned detached from the pushwire.

Manufacturer Narrative

A supplemental report is being submitted at this time due to updates made to analysis results.The pipeline flex embolization device (model: ped2-500-35; lot: a912449) was returned for analysis within a shipping box and within a plastic re-sealable pouch.The pipeline flex braid was returned detached from the pusher.One end of the pipeline flex braid was found damaged (frayed) and not found fully open.The other end of the pipeline flex braid was found open and in good condition.As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified.The pipeline flex distal hypotube does not appear to be stretched and the ptfe shrink tubing was intact; however, the shrink tubing was found pulled back from the proximal bumper.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil outer coils were found stretched and broken with the inner core wire broken.Per the sem report, ¿few original fracture features were available to determine the wire failure mechanism.¿ no other anomalies were observed.There was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ could not be confirmed.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.In addition, resistance can occur due to patient vessel tortuosity, failure to maintain a continuous flush, or pipeline is pulled back/torqued during delivery.The vessel anatomy was moderate in tortuosity and a continuous flush was maintained.Therefore, the cause could not be determined.Regarding the ¿pushwire separation¿ issue, this event is similar to events that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.However, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 9868360
• MDR Text Key: 195755345
• Report Number: 2029214-2020-00283
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: A912449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• 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: 52 YR