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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
Model Number FA-77425-20
Device Problems Positioning Failure (1158); Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/04/2016
Event Type  Malfunction  
Manufacturer Narrative

The device has not been returned for evaluation; however, return is anticipated. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Should the device be returned or additional information become available, a supplemental report will be submitted.

 
Event Description

Medtronic received information that during treatment of an aneurysm located in the ophthalmic segment of the internal carotid artery, the distal part of the device would not open. It was reported that several attempts were made, however were unsuccessful. The physician removed the device with the microcatheter and a new device was used to complete the procedure successfully. There was no patient injury.

 
Manufacturer Narrative

The pipeline pushwire and braid were returned for evaluation the capture coil was observed to have compression damage. The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified. The pipeline braid was observed to be fully open with one end having slight fraying, and the middle and other end having no damages. Pushwire kink damage was also observed. Based on the analysis findings the clinical observation could not be confirmed. We are unable to definitively determine the cause for the reported experience. It is possible that the damaged braid and braid sizing may have contributed to the reported issue. Additionally, the capture coil and the pipeline pushwire were observed to be damaged. However, the cause for the damages could not be determined. Per our instructions for use (ifu): the user should ¿select an appropriately sized ped such that its fully expanded diameter is equi valent to that of the largest target vessel diameter. An incorrectly sized ped may result in inadequate device placement, incomplete opening, or distal migration. Ancillary findings also included coating damage on the pushwire at 21. 5cm to 23. 0cm, and 37. 5cm to 38. 0cm from the distal tip coil; and 0. 5cm to 11. 0cm from the proximal end. The coating damage on the proximal end of the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve. The torque device and rhv were not returned for evaluation; therefore any contributing factors from the torque device/rhv valve could not be determined. The coating damage on the distal end was identified as delamination; a formal investigation is currently ongoing. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Search Alerts/Recalls

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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 Key5851857
MDR Text Key51343276
Report Number2029214-2016-00657
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 11/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/10/2019
Device MODEL NumberFA-77425-20
Device LOT NumberA241045
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/10/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction Number2029214-10/7/16-001-R

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