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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 Problem Foreign Body Reaction (1868)
Event Date 06/01/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there did 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. Gadara, m. (2015). Intracerebral granulomas after pipeline embolization device procedure for intracranial aneurysms; two case reports. J neuropathol exp neurol journal of neuropathology <(>&<)> experimental neurology, 74(6), 630. Doi:10. 1097/nen. 0000000000000205 mdrs related to this article: 2029214-2016-00557 2029214-2016-00558 2029214-2016-00559.
 
Event Description
Medtronic review of literature found reports of foreign body giant cell reaction and granulomas of the brain parenchyma after pipeline implantation. A patient presented with incidental bilateral paraclinoid aneurysms, which were treated four weeks apart by pipeline-supported coil embolization. Eight weeks later, mri showed bilateral predominantly subcortical enhancing lesions, with very little surrounding edema. Extensive rheumatologic and infectious disease evaluations were all negative. Follow-up mri over the next 18 months showed increased lesions in number and size. A biopsy of the left frontal lobe showed foreign body giant cell reaction and granulomas within small intraparenchymal blood vessels and subcortical white matter. Many granulomata contain foreign material. The patient was treated with a steroid. An mri was performed 3 months later which demonstrated a decrease in number and size of enhancing nodules.
 
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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 Key5784242
MDR Text Key106357331
Report Number2029214-2016-00557
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,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2016
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 Received06/14/2016
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: 07/11/2016 Patient Sequence Number: 1
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