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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative
Adeeb n, gupta r, schneider am, leadon m, enriquez a, griessenauer cj, salem m, alturki a, schmalz p, ogilvy cs, thomas aj, moore jm, defining a clopidogrel response cut-off value using light transmission aggregometry prior to pipeline embolization of unruptured intracranial aneurysms, world neurosurgery (2018), doi: 10. 1016/j. Wneu. 2018. 01. 198 the pipeline device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there does not appear to have been any defect of the device during use. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of hemorrhagic complications after pipeline placement. The purpose of this article was to define the optimal threshold light transmission aggregometry value for clopidogrel responsiveness to predict the risk of post-procedural thromboembolic complications and to help guide appropriate antiplatelet regimen. The authors identified 95 patients with 110 unruptured intracranial aneurysms treated with the pipeline embolization device (ped). The patients' median age was (b)(6) ; (b)(6) were female and (b)(6) were male. The following results were observed: - intracranial hemorrhagic complications occurred in 1 patient and resulted in transient deficits.
 
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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 Key7451773
MDR Text Key106210481
Report Number2029214-2018-00335
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
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 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
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 Received03/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 04/23/2018 Patient Sequence Number: 1
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