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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA 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 Problems Intracranial Hemorrhage (1891); Perforation (2001); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
See related regulatory report 2029214-2018-00610. Regulatory report sent as correction to include device information for second device used in procedure. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that pipeline foreshortened significantly. As a result a second pipeline was deployed in the m1. There was also in-stent thrombosis and the a1 was not visible on the angiogram. A tpa thrombolysis and pta was used to open the occlusion which resulted in an m3 perforation and hemorrhage. The patient was undergoing surgery for a left paraclinoid opthalmic aneurysm. No antiplatelet test was conducted prior to pipeline placement. The only way to assess the procedure was using the kazakh-thrombosis test which involved leaving the pipeline partially deployed in the vessel for 15 minutes to monitor the thrombosis before full delivery.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7889926
MDR Text Key120740007
Report Number2029214-2018-00802
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
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 NumberNOT-REP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
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: 09/19/2018 Patient Sequence Number: 1
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