PIPELINE FA-77375-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-21 for PIPELINE FA-77375-20 manufactured by Micro Therapeutics, Inc. Dba Ev3.

Event Text Entries

[184413904] See related regulatory report 2029214-2020-00273 and 2029214-2020-00274. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184413905] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00275
MDR Report Key9863624
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2020-03-21
Date of Report2020-03-21
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9496801345
Manufacturer G1MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePIPELINE
Generic NameINTRACRANIAL ANEURYSM FLOW DIVERTER
Product CodeOUT
Date Received2020-03-21
Model NumberFA-77375-20
Catalog NumberFA-77375-20
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-21

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