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

Model Number PED2-425-35

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis findings: the pipeline flex w/ shield device was found stuck within the catheter when attempting to advance or retract out.The catheter was cut to remove the pipeline flex w/ shield device.Dried blood was found within the catheter.The inner diameter of the catheter was measured to be 0.027¿ proximally which is within specification and compatible for use with the pipeline flex w/ shield.The distal inner diameter could not be measured as it was damaged prior/during the extraction.The pipeline flex w/ shield pusher core wire was found kinked between ~40.2cm and ~50.9cm from the proximal end.The hypotube was found stretched with the ptfe shrink tubing broken at this location.No damages were found with the proximal bumper.The distal delivery wire was separated from the hypotube proximal to the wire weld.The resheathing pad and pad restraints were found intact.The dps sleeves, dps restraints and tip coil were separated from the distal delivery wire.Once fully deployed out of the micro catheter, both ends of the braid were found fully opened, damaged and frayed.The separated distal wire was sent out for sem/eds testing.No other anomalies were observed.Based on the analysis findings, the customer report of ¿pushwire kink/damage¿ and ¿lockup/resistance at distal segment of catheter¿ were confirmed as the pipeline flex w/ shield device was returned stuck within the catheter.From the damages found on the catheter (accordioned/flattened) pusher (kinked), hypotube (stretch), dps sleeves (break), tip coil (break) and braid (damaged/frayed), it appears high force is used.It is possible these damages occurred when the customer attempted to retrieve the pipeline flex shield through the catheter against the reported resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.The distal wire of the pipeline flex delivery system was possibly detached due to the solder tensile failure when attempting to retract the pipeline flex against 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.

Event Description

Medtronic received information regarding a pipeline that had resistance and became stuck in the microcatheter.The patient was being treated for an unruptured aneurysm of the left carotid artery.Vessel tortuosity was severe.Dual antiplatelet treatment (dapt) was administered.It was reported all devices were prepared according to the instructions for use (ifu).During delivery of the pipeline stent, resistance was experience in the distal third of the microcatheter.Several attempts were made and the physician released the slack in the system but the stent would not advance and it was noted that the pushwire "sprained" multiple times.The pipeline and the catheter were removed together and it was found that the pipeline was stuck within the catheter.There was no damage observed to the catheter or the pipeline pushwire.The procedure was completed with coils.There was no harm or injury to the patient.Post-procedure angiography showed good results.Additional information received indicated there was damage to the pushwire as there were multiple twists in the proximal part of the pushwire.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11721487
• MDR Text Key: 251200472
• Report Number: 2029214-2021-00479
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2021

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: 01/25/2021
• Device Model Number: PED2-425-35
• Device Catalogue Number: PED2-425-35
• Device Lot Number: A587506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/23/2021
• Date Device Manufactured: 01/26/2018
• 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: 57 YR
• Patient Weight: 60