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

Model Number PED-300-35

Device Problem Break (1069)

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

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description (pushwire found broke).This condition was not reported at the time of the event.As received, the pipeline flex braid with delivery system was found partially deployed and protruding from within marksman distal tip.The pipeline flex braid distal end was found fully opened and damaged (frayed).The pipeline flex proximal and distal dps restraints and sleeves were found intact; however, the tip coil was found damaged.The pipeline flex braid with delivery system was pulled out from within the marksman distal tip with resistance.The re-sheathing marker was found intact; however, the re-sheathing pad, proximal pad restraint, and proximal bumper were found dislodged.The pushwire was found detached at the distal hypotube weld (solder joint).The dislodged re-sheathing pad and proximal pad restraint were found within the braid proximal end.The pipeline flex braid proximal end was found in good condition.The pusher was found separated at the distal hypotube proximal to the bumper.There was evidence of corrosion around the broken end.The remaining portion of the pusher was found missing and not returned.The ends of the detached pushwire and the separated hypotube were sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end showed presence of tin (sn).Regarding the separated hypotube, the analysis states that no original fracture features are visible on the fracture surface.We were unable to determined the cause of the event.Separation can occur if excessive force is used exceeding the tensile strength of the material.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 information that all pipeline flex was stuck inside the marksman catheter.The patient underwent embolization treatment for a small unruptured saccular posterior communicating aneurysm, measuring 5.67mmx10.1mm.Landing zone distal 2.88mm proximal 3.21mm.The vessel was normal tortuous.It was reported that during the operation, pipeline could not be pushed out from marksman.Many attempts were still not possible.No patient injury was reported.Evaluation of the returned device found that the pushwire was found detached at the distal hypotube weld (solder joint).

• 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: 9419589
• MDR Text Key: 190198711
• Report Number: 2029214-2019-01206
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: PED-300-35
• Device Lot Number: A855393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• 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: 65 YR