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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 Thromboembolism (2654)
Event Date 08/20/2015
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 implantation. The event cause could not be conclusively determined from the provided information. Mdrs related to this article: 2029214-2017-00260 2029214-2017-00261 2029214-2017-00262.
 
Event Description
Medtronic received information from literature that a patient experienced thromboembolism during pipeline implantation. The article states that a patient was undergoing pipeline implantation in the treatment of an unruptured, ophthalmic artery aneurysm. During the procedure, the patient experienced acute clot, which embolized to an m3 pre-rolandic branch. The clot resolved following intra-arterial administration of abciximab. The patient initially awoke from left-sided weakness and headache, although this significantly improved and his discharged mrs was the same as his mrs at presentation. There were no reports of device issues in connection with this event. Durst, c. R. (2015). Endovascular treatment of ophthalmic artery aneurysms: ophthalmic artery patency following flow diversion versus coil embolization. Journal of neurointerventional surgery, 8(9), 919-922. Doi:10. 1136/neurintsurg-2015-011887.
 
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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 Key6441589
MDR Text Key106085763
Report Number2029214-2017-00261
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 03/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
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 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: 03/28/2017 Patient Sequence Number: 1
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