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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 Collapse (1099)
Patient Problem Stenosis (2263)
Event Date 06/18/2015
Event Type  malfunction  
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. Brzezicki, g. (2015). Pipeline embolization device for treatment of high cervical and skull base carotid artery dissections: clinical case series. Journal of neurointerventional surgery j neurointervent surg, 8(7), 722-728. Doi:10. 1136/neurintsurg-2015-011653. Mdrs related to this article: 2029214-2016-00586, 2029214-2016-00587, 2029214-2016-00588, 2029214-2016-00589, 2029214-2016-00590.
 
Event Description
Medtronic received information from literature that a pipeline appeared collapsed after implantation. The patient initially presented with ear and jaw pain. The patient was found to have a 2x2mm pseudoaneurysm and vessel dissection. In addition, the patient had flow-limiting stenosis (95%). The parent vessel size was 5. 2mm proximal and 4. 2mm distal to the aneurysm. The patient received two pipeline devices. Three-months post-procedure, one of the pipeline devices appeared collapsed (95% stenosis) and the patient underwent angioplasty of the pipeline resulting in 50% residual stenosis. At the 10-month follow-up, ct angiography showed that the angioplastied pipeline segment collapsed again to the same degree as before. There was still preserved flow around the device. The patient remained asymptomatic and elected not to pursue further intervention. The patient remains on dual antiplatelet therapy (dapt).
 
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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 Key5804570
MDR Text Key49953975
Report Number2029214-2016-00588
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 06/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received06/21/2016
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

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