PIPELINE NV UNK PIPELINE

MAUDE Adverse Event Report

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

Event Text Entries

[184303782] See related regulatory report 2029214-2020-00267. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184303783] Griffin a, reese v, h? Seyinoglu z, et al. Predictors of clinical outcome after treatment of intracranial aneurysms with the pipeline embolization device.? World neurosurgery. 2019;130: e666-e671. Doi: 10. 1016/j. Wneu. 2019. 06. 185. Medtronic received a literature article pertaining to a study to identify predictors of adverse events associated with the pipeline. In this study the mean age was 56. 3, 80% female. The study took place between january 2014 and september 2018. 204 aneurysms in 170 patients were treated with the pipeline. 181 aneurysms were located in the anterior circulation, and 23 were found in the posterior circulation. 82% of aneurysms were saccular, followed by 11% fusiform and 4% blister. (11%). The mean aneurysm size was 8. 2mm. The neurologic mortality rate was 1. 8%, occurring in 3 patients, with deaths due to stroke, iph, or aneurysm rupture. The all-cause mortality was 2. 9%, occurring in 5 patients.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00268
MDR Report Key9860861
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-03-20
Date of Report2020-03-20
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-20
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 Received2020-03-20
Model NumberNV UNK PIPELINE
Catalog NumberNV UNK PIPELINE
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 2020-03-20

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