ENDURANT IIS BIFURCATED STENT GRAFT ESBF3614C103E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for ENDURANT IIS BIFURCATED STENT GRAFT ESBF3614C103E manufactured by Medtronic Ireland.

MAUDE Entry Details

Report Number9612164-2020-01368
MDR Report Key9887592
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-01-17
Date Mfgr Received2020-03-03
Device Manufacturer Date2018-12-13
Date Added to Maude2020-03-27
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 ContactALISON SWEENEY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Manufacturer Phone091708096
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer CountryIE
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDURANT IIS BIFURCATED STENT GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Product CodeMIH
Date Received2020-03-27
Returned To Mfg2020-02-07
Model NumberESBF3614C103E
Catalog NumberESBF3614C103E
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY IE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

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