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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
Device Problem Occlusion Within Device (1423)
Patient Problem Infarction, Cerebral (1771)
Event Date 11/17/2014
Event Type  Injury  
Event Description

Medtronic (covidien) received information regarding a manufactured device and the adverse event involved with it. Three days post procedure, it was reported the patient suffered an ischemic stroke. The pipeline was reported to have developed a clot within the device. The patient is currently unable to function independently.

 
Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was implanted in the patient. The lot history record review was not possible as the lot number was not reported. (b)(4).

 
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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
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key4547619
MDR Text Key5517595
Report Number2029214-2015-00205
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
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 01/27/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/25/2015 Patient Sequence Number: 1
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