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GORE EXCLUDER AAA ENDOPROSTHESIS Adverse Event — Injury (MDR 2017233-2008-00063)

GORE EXCLUDER AAA ENDOPROSTHESIS Adverse Event — Injury (MDR 2017233-2008-00063) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GORE EXCLUDER AAA ENDOPROSTHESIS; Generic name: ENDOVASCULAR GRAFT SYSTEM; Manufacturer: W.L. GORE & ASSOCIATES, INC..

DeviceGORE EXCLUDER AAA ENDOPROSTHESIS
Generic nameENDOVASCULAR GRAFT SYSTEM
ManufacturerW.L. GORE & ASSOCIATES, INC.
Report number2017233-2008-00063
Event typeInjury
Product problemN
Date received2008-02-19
Report sourceHealth Professional, Company representation
NarrativeAS REPORTED, IN 2007, THIS PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS. IN 2008, DURING FOLLOW-UP COMPUTED TOMOGRAPHY, IT WAS DISCOVERED THAT THE CONTRALATERAL LEG COMPONENT HAD COLLAPSED AT THE LEVEL OF THE AORTIC BIFURCATION. THE DISTAL WAIST MEASURED AT 20MM IN DIAMETER. THERE WAS NO CALCIFICATION OR THROMBUS REPORTED WITHIN THE AORTIC BIFURCATION. ON THE NEXT DAY, THIS PATIENT
SourceopenFDA MAUDE (device adverse events)

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