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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100)
Event Type  Injury  
Manufacturer Narrative
Citation: i. Szikora, z. Berentei, z. Kulcsar, et al. Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the budapest experience. Ajnr am j neurodadiol. 2010. The devices will not be returned for evaluation as they were implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patients post procedure and the cause was unknown. Mdrs related to this report: 2029214-2017-00342, 2029214-2017-00343.
 
Event Description
Medtronic received information through review of literature that clinical complications occurred in four cases. One patient had a mild postprocedural hemiparesis lasting for 2 days. The patient fully recovered, and no ischemic changes were seen on ct. This event was primarily considered the result of contrast overload due to difficulties of catheter navigation and a lengthy procedure, but a ct negative thromboembolic complication could not be excluded. One patient had an embolic occlusion of a retinal artery branch, resulting in a small visual field deficit following ped-supported coil packing of her complex paraophthalmic aneurysm. One patient who we subsequently learned had not taken her antiplatelet medication experienced acute intraprocedural in-stent thrombosis within the internal carotid artery (ica). It was initially recanalized with tirofiban (aggrastat) but re-occluded 2 days later, despite being treated with double antiplatelets. The patient had a transient hemiparesis. Having good collateral circulation, she fully recovered and the ica later recanalized. One patient experienced abrupt in-stent thrombosis resulting in a transient neurologic deficit.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6451347
MDR Text Key71459412
Report Number2029214-2017-00342
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeHU
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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 Received03/31/2017
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

Patient Treatment Data
Date Received: 03/31/2017 Patient Sequence Number: 1
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