MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-35

Device Problem Physical Resistance (2578)

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

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex delivery system was returned for evaluation without the microcatheter or pipeline device.As received, the pushwire was found to be separated at the distal hypotube.The distal segment of the pushwire was separated and not returned.The distal hypotube was also found to be stretched with the ptfe shrink tubing still intact.The pushwire was observed to be bent.No other anomalies were observed.The broken end was sent out for scanning electron microscope (sem) analysis.Based on the sem analysis, it appears the pushwire separation was secondary to tensile overload.We are unable to definitively determine the cause of the tensile overload; however the pushwire separation; pushwire (bending) and hypotube (stretching); suggest that excessive forced was used; subsequently causing the pushwire to become separated.Per our instructions for use (ifu): ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿ in addition, review of this device lot history record was conducted and no issues were identified that could have contributed to this event.All products are 100% inspected for damage and irregularities during manufacture.

Event Description

Medtronic received information that during treatment of an aneurysm located in the supraclinoid segment of the left internal carotid artery, the device was advanced through a curve of the artery and became stuck at the distal segment of microcatheter.The physician then attempted to remove the device with the microcatheter, however part of the hub which was outside the patient was stuck/jammed and didn't allow him to remove the device.It was reported that the only way to retrieve the device was by pushing forward and the device released outside of the patient.The patient was treated by carotid artery occlusion.No patient injury was reported.Through device analysis the push wire of the device was found separated at the distal hypo-tube.

Manufacturer Narrative

Information received from the same report as mfr: 2029214-2016-00129.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5723715
• MDR Text Key: 47354386
• Report Number: 2029214-2016-00395
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/04/2018
• Device Model Number: PED-475-35
• Device Lot Number: A037029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• 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