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

Model Number PED-275-20

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex pusher was protruding from within the marksman catheter hub for ~59.0cm.The marksman catheter body was found acco rdioned from ~26.7cm to ~23.5cm from the distal tip.In addition, the marksman catheter body was found flattened at ~6.5cm from the distal tip.No damage was found with the marksman distal marker/tip.The marksman catheter total length was measured to be ~158.5cm and the useable length was measured to be ~151.0cm which is within specification (specification: 150cm ± 3cm).The pipeline flex pusher was removed (pulled out) from with the marksman catheter without issue.The distal hypotube with ptfe shrink tubing was found intact.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 coil) were found detached.The marksman catheter was dissected (cut) and the pipeline flex distal segment found stuck at ~58.5cm from the proximal end of the hub (~100.0cm from distal tip).The pipeline flex distal segment was removed from within the marksman catheter.The resheathing pad and marker were found in good condition.The pipeline flex braid was found deployed on the pushwire.The pipeline flex braid proximal end was found open, but damaged (frayed).It is likely some damage occurred during removal from within the marksman catheter.The pipeline flex braid distal end was found open and in good condition.The ptfe sleeves with restraints were found intact.The tip coil was found detached from the distal core wire.The distal core wire appears to have been broken.The marksman catheter was re-dissected (cut) and the tip coil found stuck at ~6.5cm from the distal tip.The tip coil was removed from within the marksman catheter.The tip coil was found bent.The d etached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows the presence of tin (sn).The pipeline flex distal pushwire was sent out for sem (scanning electron micrographic) analysis.Per the sem report, the wire end exhibits significant corrosion.No other anomalies were observed.The pipeline flex embolization device and marksman catheter will be retained as per (b)(4).Based on the device analysis and reported information, the customer¿s report of ¿resistance¿ and ¿catheter damage¿ were confirmed.From the damages seen with the pipeline flex (pusher separation) and the marksman catheter (accordioning) it appears excessive force was used.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, it is likely the damage found with the marksman catheter (flattening) contributed to the resistance.However, the cause for the catheter damage could not be de termined.As the analysis showed presence of soldering material (tin); thereby indicating that the sold ering was conducted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline stent and marksman microcatheter that had resistance during a procedure when the marksman was damaged.The patient was being treated for a ride side unruptured saccular aneurysm of the middle cerebral artery with coils filling and stent placement for blood flow diversion.The aneurysm max diameter was 5.5mm and the neck diameter was 3.5mm.Vessel tortuosity was moderate.It was reported that the devices were prepared according to the instructions for use (ifu).The marksman catheter was in place in the distal middle cerebral artery.The pipeline stent was advanced through the catheter but became stuck at the distal end.Both devices had to be withdrawn together from the patient's body.Upon removal from the patient it was discovered that the distal end of the catheter was flattened.There was no damage noted/reported to the pipeline or pipeline pushwire.The catheter had been flushed continuously with heparinized saline per ifu.Both devices were replaced to continue the procedure.There was no harm or injury to the patient.Post-procedure angio revealed partial contrast agent residue remained but no procedure or device issue was reported.

• 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: 10673014
• MDR Text Key: 215552608
• Report Number: 2029214-2020-01024
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536014671
• UDI-Public: 00847536014671
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2021
• Device Model Number: PED-275-20
• Device Catalogue Number: PED-275-20
• Device Lot Number: A677681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Date Manufacturer Received: 10/08/2020
• Date Device Manufactured: 07/18/2018
• 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: 52 YR