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

Model Number UNKNOWN

Device Problem Break (1069)

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

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

As the device was received, found that pipeline flex pushwire was found separated proximal to the dps sleeves. This device issue did not reported during the time of the event. This device received as an extra device. Unknown pipeline flex embolization device was returned medtronic catheter. The pipeline flex delivery system was returned outside the catheter. No bends or kinks were found with the pipeline flex pushwire. The pipeline flex distal hypotube was found stretched. The ptfe shrink tubing was intact but pulled back from the proximal bumper. The proximal bumper, re-sheathing pad and re-sheathing marker were found intact. The pipeline flex pushwire was found separated proximal to the dps sleeves. The pipeline flex dps sleeves with tip coil were not returned. The pipeline flex braid was found within the catheter hub. The catheter body was cut proximal to the catheter kinking. A mandrel was inserted into the catheter and the pipeline flex braid was pushed out from within the catheter hub. The pipeline flex braid ends were found fully opened and in good condition. The pipeline flex dps sleeves with tip coil were not found with the catheter. No other anomalies were observed. The pipeline flex pushwire will be sent out for sem failure analysis. Per the sem report, most of the fracture surface was smeared and corroded. Small areas exhibited dimple features consistent with a torsional overload failure. The customer did not reported this event. Without any detail of the event, we were unable to determined the cause of the event. Pushwire break/separation can be caused by patient vessel tortuosity, resistance of delivery wire during delivery/retrieval, over-manipulation, or user resheaths more than 2 times. From the damages seen with the pipeline flex pushwire, it appears there was high force used. It is likely these damages occurred when the attempted to advance the pipeline flex through the catheter against resistance. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received extra device for analysis. Evaluation of the extra returned device found that pipeline flex pushwire was found separated proximal to the dps sleeves.

• 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: 9720537
• MDR Text Key: 196774922
• Report Number: 2029214-2020-00151
• 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: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

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