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U.S. Department of Health and Human Services

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

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MEDTRONIC COVIDIEN PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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).

 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL 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 Key5511531
MDR Text Key40728633
Report Number2029214-2016-00155
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2016
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 Manufacturer02/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2016
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

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