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

Model Number PED-475-30

Device Problem Break (1069)

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

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description.The pipeline flex device coil tip and pushwire was found separated from the hypotube at the distal hypotube weld (solder joint).This condition was not reported during the time of the event.As the device returned for analysis found, the pushwire coil tip and braid were partially pushed outside of the catheter tip with the exposed braid end frayed.The pushwire was retracted out of the microcatheter with no resistance encountered.No damages or irregularities were found with the pipeline flex pushwire; however, the coil tip and pushwire was found separated from the hypotube at the distal hypotube weld (solder joint).The braid subassembly and detached pushwire were pulled out of the distal end of the catheter with resistance encountered.Once removed from the catheter and hydrated, the distal and proximal ends of the pipeline flex braid fully opened, and the distal end of the braid was confirmed to be frayed while the proximal end had no damage.The tip coil was found stretched.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).Based on the reported information and analysis findings, we were unable to determined the cause of the event.From the damages seen on the catheter body (crush/stretching/accordioning), pipeline flex braid (frayed distal end) and pusher (coil tip stretching/separation of solder joint); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retract the pipeline flex through the marksman catheter against resistance.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 pipeline flex device could not be pushed out of the medtronic microcatheter.Then the microcatheter was replaced and the procedure was completed without any problems.Post procedural angiogram showed that everything was alright.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 8.99mm x 8.63mm located in the cavernous segment of the internal carotid artery (ica).The proximal and distal landing zone was 4.29mm x 4.88mm.The patient¿s vasculature was normal in tortuosity.Evaluation of the returned device found that the pipeline flex device coil tip and pushwire was found separated from the hypotube 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: 9444120
• MDR Text Key: 199914145
• Report Number: 2029214-2019-01212
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2022
• Device Model Number: PED-475-30
• Device Lot Number: A826463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2019
• 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: 56 YR