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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77450-18
Device Problems Detachment Of Device Component (1104); Delamination (2904)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2015
Event Type  Malfunction  
Event Description

Medtronic (covidien) received information that during a treatment of a right internal carotid artery giant partially thrombosed aneurysm with a pipeline embolization device and coils, the physician reported that the green coating in the delivery wire of the pipeline delaminated and detached from pipeline pushwire. The pipeline device was implanted successfully. No patient injury was reported as a result of this procedure.

 
Manufacturer Narrative

The lot history record of the reported lot number has been reviewed and no quality issues were noted. The pipeline delivery system (pushwire) and microcatheter were returned for evaluation without the pipeline. Per the initial report, the pipeline was implanted in the patient. Evaluation is still in progress and results pending completion of evaluation. A supplemental mdr wil be completed once the device evaluation results become available.

 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key4700130
MDR Text Key18926424
Report Number2029214-2015-00386
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/18/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/08/2016
Device MODEL NumberFA-77450-18
Device LOT Number9786527
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/24/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/09/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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