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

Model Number PED-400-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

As the device was received in a condition was contradictory to the complaint description.The pipeline flex device tip coil ball was found missing.This condition was not reported at time of the event.The pipeline flex embolization device was returned for analysis.The pipeline flex embolization device was returned within its introducer sheath.No damages were found with the introducer sheath.The pipeline flex embolization device appears to be in good condition within the introducer sheath.The tip coil was partially pushed out from within the introducer sheath.No bends or kinks were found with the tip coil; however, the tip coil ball was found missing.Upon re-sheathing the tip coil, the braid detached from the pushwire and became stuck within the introducer sheath.The pushwire was pulled out from within the introducer sheath.The pushwire shrink tubing was found pulled back from the proximal bumper.The re-sheathing pad outer silicone was found damaged and prolapsed.The tip coil, distal marker, and ptfe sleeves were found dislodged from the distal pushwire.The ptfe sleeves were removed from within the introducer sheath.However, the tip coil and distal marker were likely lost during handling.The ptfe sleeves were found to be still in good condition.The pipeline flex braid was removed from within the introducer sheath.The braid ends were found fully open and in good condition.No other anomalies were observed.Based on the device analysis and reported information, we were unable to determined the cause of the event.As the returned tip coil was found damaged.It is possible that the introducer sheath was not seated deeply in the hub of the catheter during the delivery, causing resistance during delivery; which led to damage to the tip coil.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that resistance was encountered at the when the pipeline was attempted to be advance into the hub of the m icrocatheter.There was no damage to the devices.The device was prepared per the instructions for use (ifu).The catheter was flushed as indicated in the ifu.Evaluation of the returned device found that the tip coil ball was found missing.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9935919
• MDR Text Key: 208811442
• Report Number: 2029214-2020-00346
• Device Sequence Number: 1
• Product Code: OUT
• 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: Physician
• Type of Report: Initial
• Report Date: 04/07/2020

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: 09/15/2022
• Device Model Number: PED-400-16
• Device Lot Number: A898562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• 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: 58 YR