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

Device Problems Break (1069); Flaked (1246)

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

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis and the investigation is currently in progress.A supplemental will be submitted upon completion.Information received from the same report as mfr: 2029214-2015-05238.

Event Description

Medtronic received information that during treatment of an aneurysm located in cavernous segment of the left internal carotid artery, separation of the distal tip of the pushwire of the device occurred.It was reported that there was a lot resistance in the distal segment during pushing of the pipeline device and during retraction after pipeline deployment.There were no patient complications reported.

Manufacturer Narrative

The clinical observation of pushwire tip separation was confirmed.The pipeline flex delivery system and microcatheter were returned for evaluation without the pipeline as it was implanted in the patient.As received, the pushwire was found to be separated 2.0 cm from the distal tip of the pushwire.The pushwire appeared to be bent 80.0 cm from the proximal end.The detached pushwire was sent out for further sem testing.The sem results were consistent with ductile features that are indicative of overload failure.We are unable to definitively determine the cause of overload failure; however, it is possible that the ¿excessive resistance during delivery and retrieval¿ may have contributed to the reported issues causing the pushwire to become bent and separated.Per the instructions for use (ifu): the user should ¿discontinue delivery of the device if high force or excessive friction is encou ntered 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 microcatheter, or the vessel.The lot history record of the reported lot number showed no quality issues against the lot and no other anomalies were found during the document review.All devices are 100% inspected for damage and irregularities during the manufacturing process.Ancillary findings not related this event observed during analysis include coating damage caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve near the distal end of the pushwire.The torque device and rhv were not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined.(b)(4).

• Brand Name: PIPELINE
• 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: 5511531
• MDR Text Key: 40728633
• Report Number: 2029214-2016-00155
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P100018.S004
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• 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: N
• Patient Sequence Number: 1