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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 NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 04/21/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Jiang, b. , bender, m. T. , westbroek, e. M. , campos, j. K. , lin, l. -m. , xu, r. , tamargo, r. J. , huang, j. , colby, g. P. , <(>&<)> coon, a. L. (2018). Procedural complexity independent of p2y12 reaction unit (pru) values is associated with acute in situ thrombosis in pipeline flow diversion of cerebral aneurysms.  stroke and vascular neurology, 3(3), 169¿175. Https://doi. Org/10. 1136/svn-2018-000150 medtronic received a literature article pertaining to a cohort of 37 ped cases with acute in situ thrombosis (mean age 53. 8 years, mean aneurysm size 8. 4 mm) that was matched with a cohort of 705 ped cases without intraprocedural thromboembolic events (mean age 56. 4 years, mean aneurysm size 6. 9 mm). The two groups were evenly matched in patient demographics, previous treatment/subarachnoid hemorrhage (sah), and aneurysm location. The study took place between april 2011 and august 2017, during which a total of 742 consecutive ped/ped flex cases were performed. Of these 742 cases, 37 were identified to have acute in situ thrombosis intraprocedural. The remaining 705 cases did not have acute ischaemic intraprocedural complications. One patient died in the in situ thrombosis group, 7 patients in the control group.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11490450
MDR Text Key239978698
Report Number2029214-2021-00294
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
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 Received02/15/2021
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: 03/15/2021 Patient Sequence Number: 1
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