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

Model Number PED-400-20

Device Problem Break (1069)

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

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
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pipeline flex w/shield technology model #
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ped2-400-20 as the device was received, pipeline flex with shield device was partially within an introducer sheath with the braid and distal sub -assemblies found stuck within the hub of the medtronic catheter. Strong resistance was felt when removing the pipeline flex with shield device form the medtronic catheter. The dps wing, and tip coil outer coil broke and became stuck within the proximal end of the catheter along with the braid subassembly. Distal inner wire that is normally under the tip coil outer coil was found intact. No damages or irregularities were found with the pushwire. The distal and proximal dps restraints were found to be intact. The hypotube appeared to be intact and with no stretching and the ptfe shrink tubing was found still intact. No damages were found with the distal marker, re-sheathing marker or with the proximal bumper. A tweezer was used to pull out the braid from the catheter hub. The proximal end of the braid fully opened with fraying observed. The distal end of the braid did not fully open (hourglass) with fraying observed. The dps wing was found entangled with the braid fiber. The braid subassembly was placed within an ultrasonic cleaner and the braid fully opened once the coagulated blood was dissolved. The catheter was cut, and a mandrel was used at the proximal section. Dried blood and the tip coil outer coil were pushed out. Both solder ends of outer coil was broken however the coil itself appears undamaged. Based on the returned device analysis, these damages occurred when the customer attempted to retract the pipeline flex with shield device through the catheter and into the sheath against resistance. From the damages seen on pipeline flex with shield braid (frayed ends), tip coil outer coil (break) and dps wings (break); it appears there was high force used. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the pipeline encountered difficulties when it was used with the marksman catheter. The pipeline was able to exit the catheter tip and encounter resistance when attempted to be resheathed. The resistance was in the middle distal section. The pipeline was not implanted and was removed with the catheter. The devices were prepared and used per the instructions for use. The catheter was flushed as per the ifu. This event occurred during treatment of an unruptured, cavernous aneurysm, that was fusiform. The anatomy was moderate in tortuosity. Evaluation of the returned device found that the dps wing, and tip coil outer coil broke from the pushwire.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 9813960
• MDR Text Key: 207393251
• Report Number: 2029214-2020-00211
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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

• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/09/2020
• Device Model Number: PED-400-20
• Device Lot Number: A457749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial