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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN, IRVINE PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
The reported device remains implanted in the patient. Therefore, product evaluation cannot be performed. The cause of the event cannot be conclusively determined. From available information. There was no evidence of product failure. Linked mdr's 2029214-2017-01533 2029214-2017-01534, 2029214-2017-01535.
 
Event Description
Medtronic received information that a patient's aneurysm recanalized after being treated with medtronic coils, an aneurysm bridging device, and a pipeline flex device about a year ago. The patient's aneurysm located at the cavernous segment of the internal carotid artery. It had max diameter of 10. 2mm and neck width of 5. 3mm. Landing zone artery sizes were 4. 3mm distally and 4. 8mm proximally. Vessel tortuosity was describe as normal. The patient was being retreated with flow diverter.
 
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Brand NamePIPELINE FLEX 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 Key7123761
MDR Text Key95049997
Report Number2029214-2017-01354
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? No
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: 12/15/2017 Patient Sequence Number: 1
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