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

Model Number PED-375-35

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The marksman total length was measured to be ~157.4cm and the useable length was measured to be ~149.9cm which is within specification (specification: 150cm ± 3cm).The pipeline flex pusher was found protruding from within the marksman catheter hub for ~59.0cm.The marksman catheter body was found accordioned at ~16.7cm and ~17.8cm from the proximal end and ~40.4cm, 30.2cm, 28.8cm, and from ~28.2cm to ~24.7cm from the distal tip.No damages were found with the marksman distal marker/tip.The pipeline flex pusher was able to be pulled out from within the marksman catheter with slight resistance.The distal hypotube was found stretched with the ptfe shrink tubing pulled back.The pusher was found detached at the distal hypotube weld (solder joint).The pipeline flex distal segment (resheathing pad/marker, braid, ptfe sleeves, distal marker, and tip c oil) were found detached.The marksman catheter was dissected (cut) and the pipeline flex distal segment was removed from within.The proximal resheathing pad restraint was found loose (detached) from the pushwire.The resheathing pad and marker were found in good condition.The pipeline flex braid was found deployed on the pushwire.The braid proximal and distal ends were found open.The braid proximal end was found to be in good condition; however, the braid distal end was found damaged (frayed).The ptfe sleeves appear to be in good condition.The tip coil was found loose (detached) on the distal pushwire with the ball weld missing.The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows elevated iron (fe), tin (sn), chromium (cr), sodium (na), and oxygen (o).No other anomalies were observed.There was an indication that the event could be related to a potential manufacturing issue; therefore, a device history record review will be performed.Based on the device analysis and reported information, the customer¿s reports of ¿lockup/resistance at distal segment of catheter¿ and ¿catheter accordion¿ were confirmed.From the damages seen with the pipeline flex (pusher detachment, stretched hypotube, braid damage) and marksman catheter (accordioning); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against resistance.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous 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.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a marksman catheter and pipeline that had resistance during a procedure.The patient was being treated for an unruptured saccular aneurysm.The aneurysm max diameter was 11.77mm and the neck diameter was 9.21mm.Vessel tortuosity was moderate.It was reported that there was resistance with a pipeline stent in the distal end of the marksman microcatheter.The surgeon attempt to removed the slack but this did not resolve the issue.The devices were removed together and damage was observed to the catheter.The devices had been prepared and the catheter continuously flushed according to the manufacturer instructions for use.There was no apparent damage to the pushwire.The devices were both replaced to continue the procedure.There was no harm or injury to the patient.The device was placed in a curve in the vessel.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10446478
• MDR Text Key: 206583678
• Report Number: 2029214-2020-00831
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015784
• UDI-Public: 00836462015784
• 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
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: PED-375-35
• Device Catalogue Number: PED-375-35
• Device Lot Number: A658653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Date Manufacturer Received: 08/21/2020
• Date Device Manufactured: 06/11/2018
• 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: 69 YR