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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-71475-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stenosis (2263)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. Wu h, wang m, li k, wang f. Treatment of extracranial vertebral artery aneurysm with flow diversion. World neurosurg. 2020;138:328-331. Doi:10. 1016/j. Wneu. 2020. 03. 064. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Wu h, wang m, li k, wang f. Treatment of extracranial vertebral artery aneurysm with flow diversion. World neurosurg. 2020;138:328-331. Doi:10. 1016/j. Wneu. 2020. 03. 064. Medtronic literature found reported of patient complications in association with a pipeline embolization device. The purpose of this article was to treat a (b)(6) woman, which computed tomography angiography demonstrated a right extracranial vertebral artery aneurysm. The saccular aneurysm (7. 9 3 6. 6 mm) was demonstrated on digital subtraction angiography at the v3 segment of the right vertebral artery. A pipeline embolization device was placed in the diseased parent artery. The patency of the pipeline embolization device was confirmed at 12-month follow-up. This article does not state any technical issues during the use of the pipeline. The following intra- or post-procedural outcomes were noted: case 1: moderate in-stent stenosis was observed at 3-month follow up. The anti-platelet therapy was prolonged with aspirin and clopidogrel for another year. At the 12-month follow-up, there was no progression of the in stent stenosis.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10325906
MDR Text Key203823550
Report Number2029214-2020-00732
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberFA-71475-25
Device Catalogue NumberFA-71475-25
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 Received07/21/2020
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: 07/27/2020 Patient Sequence Number: 1
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