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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-77375-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hydrocephalus (3272)
Event Type  Death  
Manufacturer Narrative
See related regulatory report 2029214-2020-00273 and 2029214-2020-00274. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Wang, j. , jia, l. , duan, z. , wang, z. , yang, x. , zhang, y. , & lv, m. (2019). Endovascular treatment of large or giant non-saccular vertebrobasilar aneurysms: pipeline embolization devices versus conventional stents.   frontiers in neuroscience, 13, 1. This study was performed to retrospectively analyze the safety and efficacy of a flow diverter in treating large and giant non-saccular aneurysms. The study took place between january 2014 and june 2018, with 11 female patients and 31 male patients. The complete occlusion rate was 90. 2%, the mrs score was 0 to 2, excellent in 97. 5% of patients. One patient with an aneurysm size of 21. 2 mm had a sudden severe headache 1 day post procedure. A subarachnoid hemorrhage was confirmed by ct scan, showing a hunt-hess scale of 2. The last mrs score was 1. Another patient with an aneurysm size of 23. 1 mm died from severe brainstem compression 3 days post procedure. The last mrs score was 6. The last patient with an aneurysm size of 25. 6 mm died from severe brain stem compression 2 days post procedure. The last mrs score was 6. Occlusion was seen with 4 patients, aneurysm enlargement in 1 patient, poor clinical outcome in 2 patients.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9863624
MDR Text Key184413904
Report Number2029214-2020-00275
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S004
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 03/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFA-77375-20
Device Catalogue NumberFA-77375-20
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 Received03/09/2020
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

Patient Treatment Data
Date Received: 03/21/2020 Patient Sequence Number: 1
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