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

Model Number PED2-300-18

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline became stuck in the distal segment of the marksman microcatheter during deployment.It was noted a continuous flush had been used, the physician released the load which did not resolve the issue, and there was no damage observed to the catheter or pushwire.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results were okay.The patient was undergoing surgery for treatment of an amorphous, ruptured aneurysm of the right anterior communicating (acom) artery with a max diameter of 2 mm and a 2 mm neck diameter.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered, but the platelet reactivity units (pru) level was unknown.

Manufacturer Narrative

The event is reported at this time based on analysis results which indicated a reportable device issue.Product analysis: the pipeline flex w/ shield device and marksman micro catheter were returned for analysis within a shipping box and within an opened pipeline flex w/ shield outer carton.No flash or voids molded were found within the marksman catheter hub.The pusher was found extending out the hub ~36.5cm.No damages or anomalies were found with the catheter hub.The marksman catheter body was found accordioned at ~29.5cm, ~27.0cm and between ~25.5cm and ~22.5cm from the distal end.No damages or irregularities were found with the distal tip and marker band.The pipeline flex w/ shield tip coil and distal braid were found extending out of the catheter distal tip.The pipeline flex w/ shield device was extracted out of the catheter against high resistance.No damages were found with the pipeline flex w/ shield proximal pusher.The hypotube was found intact and unstretched with the ptfe shrink tubing intact.The distal delivery wire was found separated from the hypotube proximal to the wire weld.The resheathing pad, proximal bumper and resheathing marker were found still on the distal wire and found undamaged.The ptfe dps sleeves was found undamaged.No damages or stretching was observed with the tip coil.Once retracted out of the catheter, both ends of the braid were found fully opened with damage found on both ends.The separated distal wire was sent out for eds analysis.Based on the analysis findings, the customer report of ¿lockup/resistance at distal segment of catheter¿ was confirmed.Possible causes are damaged catheter, damage to ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, user pulls back on/torques wire advancing ped in micro catheter.Customer reported continuous flush was used, no damages were observed to catheter or pushwire, devices were prepared per ifu and patient vessel tortuosity as severe.From the damages seen on the braid (damaged); distal wire (separation), catheter (accordion); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex w/ shield through the marksman catheter against the reported resistance.Possible contributors towards the failure are patient vessel tortuosity, or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.The distal wire of the pipeline flex w/ shield delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex w/ shield against the reported resistance.A review of the manufacturing process did not uncover any deficiencies with regards to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.In addition, the elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that led to the detachment issues.There is no indication that the event is related to a potential manufacturing issue.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
• MDR Report Key: 12611881
• MDR Text Key: 282040487
• Report Number: 2029214-2021-01263
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2023
• Device Model Number: PED2-300-18
• Device Catalogue Number: PED2-300-18
• Device Lot Number: B099922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Date Manufacturer Received: 10/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1