PIPELINE FLEX W/SHIELD TECHNOLOGY PED2-375-14

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for PIPELINE FLEX W/SHIELD TECHNOLOGY PED2-375-14 manufactured by Micro Therapeutics, Inc. Dba Ev3.

MAUDE Entry Details

Report Number2029214-2020-00313
MDR Report Key9908215
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-20
Date Mfgr Received2020-03-17
Device Manufacturer Date2018-12-18
Date Added to Maude2020-03-31
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 ContactMGR. KATCHA 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 FLEX W/SHIELD TECHNOLOGY
Generic NameINTRACRANIAL ANEURYSM FLOW DIVERTER
Product CodeOUT
Date Received2020-03-31
Returned To Mfg2020-01-29
Model NumberPED2-375-14
Lot NumberA757213
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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