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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 Therapeutic Response, Decreased (2271)
Event Date 08/20/2015
Event Type  Injury  
Manufacturer Narrative
The pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the reported information, there did not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and the cause could not be conclusively determined from the reported information. Mdrs related to this article: 2029214-2017-00260 2029214-2017-00261 2029214-2017-00262. 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
Medtronic received information from literature of retreatment after pipeline implantation. The purpose of this article was to evaluate the effect of flow diversion on the patency of the ophthalmic artery when treating ophthalmic artery. The authors retrospectively evaluated 19 patients who underwent pipeline implantation in the treatment of unruptured, ophthalmic artery aneurysms. Of the patients, 16 were female, 3 were male; average age was 53. 2 years. Patients underwent follow-up imaging at 6- and 12-months post-implantation. Patients who demonstrated residual aneurysm filling at 6 months were initially asked to stop taking clopidogrel. If the aneurysm still did not thrombose, the patients underwent retreatment at or after 12 months in which an additional pipeline was implanted. The article states that 2 of the 19 patients underwent retreatment. The article states that the two of the pipeline patients experienced ¿major complications¿; no further details were provided on the complications. 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 Key6441586
MDR Text Key71093649
Report Number2029214-2017-00260
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 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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