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GORE EXCLUDER AAA ENDOPROSTHESIS Adverse Event — Injury (MDR 2953161-2008-00036)

GORE EXCLUDER AAA ENDOPROSTHESIS Adverse Event — Injury (MDR 2953161-2008-00036) 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 number2953161-2008-00036
Event typeInjury
Product problemN
Date received2008-02-18
Report sourceHealth Professional, Company representation
NarrativeIN 2003, A GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE DIAMETER OF THE PATIENT'S ANEURYSMAL SAC INCREASED FROM 62 MM TO 68 MM WITHOUT ANY INDICATION OF AN ENDOLEAK. A PLAN FOR REPAIR HAS NOT YET BEEN MADE.
SourceopenFDA MAUDE (device adverse events)

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