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

Model Number PED-400-20

Device Problems Fracture (1260); Solder Joint Fracture (2324)

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

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

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.As received, the pipeline flex embolization device was returned within the medtronic catheter.The pipeline flex pushwire was found protruding from within the catheter hub.The pipeline flex tip coil was found protruding from within the marksman distal marker/tip.The pipeline flex embolization device could not be pushed forward or removed from within the catheter.The catheter was dissected (cut) to remove the pipeline flex embolization.The pipeline flex embolization device was found separated into three segments while still within the catheter.The pipeline flex embolization device segments were removed from within the catheter.The distal hypotube with the ptfe shrink tubing was found intact.The pushwire was found detached at the distal hypotube weld (solder joint).The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The pipeline flex pushwire was found separated at both proximal and distal to the dps restraints/sleeves.The dps restraints/sleeves appear to be in good condition.The tip coil outer coils were stretched.The tip coil inner core wire was found broken within the outer coils.The pipeline flex braid ends were found fully open.The pipeline flex proximal braid end appears to be in good condition; however, the distal end was found damaged (frayed).The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.In addition, the separated pushwire ends were sent out for sem failure analysis.Regarding the separation proximal to the dps restraints/sleeves, a large amount of the wire end exhibit corrosion damage.The fracture features on the remaining fracture surface indicate a torsional overload failure mechanism.Regarding the separation distal to the dps restraints/sleeves, no original fracture features are visible and it is not possible to determine the failure mechanism of the subject wire.From the damages seen with the pipeline flex (pushwire detachment/separation, braid damage); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the catheter against resistance.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and t ortuous anatomies.In addition, resistance can occur due to failure to maintain a continuous flush or pipeline is pulled back/torqued during delivery.However, the cause for the resistance could not be determined.Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that resistance was felt when the pipeline flex was advanced through the distal section of the medtronic microcatheter.The devices were prepared and used per the instructions for use (ifu).A continuous flush was used.Attempts to release the load were made but were unsuccessful.The anatomy was normal.No patient injury occurred.The patient underwent embolization treatment for a small unruptured amorphous aneurysm, measuring 3mmx2mm, landing zone distal 3.7mm proximal 4.1mm evaluation of the returned device found that the pushwire was found detached at the distal hypotube weld (solder joint).The pipeline flex pushwire was found separated at both proximal and distal to the dps restraints/sleeves.The tip coil inner core wire was found broken within the outer coils.

• 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: 9873669
• MDR Text Key: 202542175
• Report Number: 2029214-2020-00293
• 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: 03/24/2020

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: 06/21/2022
• Device Model Number: PED-400-20
• Device Lot Number: A852547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2019
• 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