AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-29 for AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) manufactured by W.l. Gore & Associates.

MAUDE Entry Details

Report Number3007284313-2019-00363
MDR Report Key9391813
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-29
Date of Report2019-11-01
Date of Event2019-10-01
Date Added to Maude2019-11-29
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 ContactJOERG KERSTEN
Manufacturer Street1500 N. 4TH STREET
Manufacturer CityAZ
Manufacturer Phone9285263030
Manufacturer G1MEDICAL PHOENIX 2 B/P
Manufacturer Street32470 N. NORTH VALLEY PARKWAY
Manufacturer CityPHOENIX AZ 85085
Manufacturer CountryUS
Manufacturer Postal Code85085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Product CodeMIH
Date Received2019-11-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerW.L. GORE & ASSOCIATES
Manufacturer AddressFLAGSTAFF AZ


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-29

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