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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE 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 09/15/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient. Attempts have been made to obtain additional information, however, our attempts have been unsuccessful. Based on the reported information, the device initially performed as intended, as indicated by successful deployment of the device in the intended located. It is unknown what caused the aneurysm to be incompletely occluded and its cannot be reliably determined; however, per the reported information, the most likely cause for the complaint is the patient condition. 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.
 
Event Description
Citation: collar sign in incompletely occluded aneurysms after pipeline embolization: evaluation with angiography and optical coherence tomography. Griessenauer cj1, gupta r2, shi s2, alturki a2, motiei-langroudi r2, adeeb n2, ogilvy cs2, thomas aj2. Ajnr am j neu roradiol. 2017 feb;38(2):323-326. Doi: 10. 3174/ajnr. A5010. Epub 2016 nov 10. Medtronic received report of 17 aneurysms that were incompletely occluded, 2 of these aneurysms underwent retreatment with a second flow diverter device.
 
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Brand NamePIPELINE
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
medtronic miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key6448102
MDR Text Key71323729
Report Number2029214-2017-00289
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,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2017
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 Received03/03/2017
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: 03/30/2017 Patient Sequence Number: 1
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