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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 Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Paralysis (1997); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Zaeske c, goertz l, dorn f, et al. Comparative analysis of the pipeline and the derivo flow diverters for the treatment of unruptured intracranial aneurysms¿a multicentric study.  world neurosurgery. 2021;145:e326-e331. Doi:10. 1016/j. Wneu. 2020. 10. 062 medtronic received a literature article pertaining to 62 patients with unruptured aneurysms who were treated with a pipeline device between 2011 and 2019. The average age of the patient's was 52 years, with 55 female and 7 male. Multiple devices were used in 22 patients. Procedural adverse events occurred in 4 cases, including 3 thromboembolic events and 1 hemorrhagic event. Morbidity occurred in 2 total patients. There was no related mortality. There were 2 cases of ischemic stroke. The first patient developed an acute minor paresis of the right leg. Computed tomography angiography revealed acute in-stent thrombosis. Due to minor neurologic sequelae, nihss
=
2, and anticipated good collateralization, no further recanalization attempt was conducted. Magnetic resonance imaging showed few punctuate embolic infarctions in the middle cerebral artery territory. At 6-month follow-up, the patient was asymptomatic with mrs
=
0. The second patient exhibited an intradural left-sided internal carotid artery aneurysm. After the treatment, the patient suffered moderate right-sided hemiparesis. An immediately initiated digital subtraction angiography did not show any thromboembolic complications, but magnetic resonance imaging revealed several foci of thromboembolic infarctions. The patient recovered partially until 6-month follow-up, showing mrs
=
2.
 
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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 Key11781066
MDR Text Key249265808
Report Number2029214-2021-00545
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
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: 05/05/2021 Patient Sequence Number: 1
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