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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); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Therapeutic Response, Decreased (2271)
Event Date 05/18/2017
Event Type  Injury  
Manufacturer Narrative
Adeeb n, griessenauer cj, foreman pm, moore jm, motiei-langroudi r, chua mh, gupta r, patel as, harrigan mr, alturki ay, ogilvy cs, thomas aj, comparison of stent-assisted coil embolization and pipeline embolization device for endovascular treatment of ophthalmicsegment aneurysms: a multicenter cohort study, world neurosurgery (2017), doi: 10. 1016/j. Wneu. 2017. 05. 104. The pipeline devices will not be returned for evaluation as they remain implanted in the patients; product analysis cannot be performed. Based on the provided information, there does not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and its cause could not be conclusively determined from the information provided in the article. 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 literature review found a report of patient complications after pipeline implantation. The purpose of this article was to present a comparative study of endovascular treatment options for ophthalmic segment aneurysms of the internal carotid artery (ica). The authors compared stent-assisted coil embolization and flow diversion (pipeline embolization device). In this pipeline group, 91 patients underwent treatment for 106 aneurysms. Of the pipeline patients, 92. 5% were female and the median age was 57 years. The article states that the following outcomes were observed in the pipeline group: - 1 patient underwent endovascular retreatment after pipeline implantation - 5 patients experienced a post-treatment mrs of 3-6; baseline mrs of these patients was not provided. - 8 patients experienced worsened mrs on follow-up. - 10 patients experienced neurological complications - 8 patients experienced thromboembolic complications - 2 patients experienced hemorrhagic complications - 1 patient experienced permanent visual deficit.
 
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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 Key6757380
MDR Text Key81509627
Report Number2029214-2017-00927
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 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
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 Received07/07/2017
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: 08/01/2017 Patient Sequence Number: 1
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