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..
| Device | GORE EXCLUDER AAA ENDOPROSTHESIS |
|---|---|
| Generic name | ENDOVASCULAR GRAFT SYSTEM |
| Manufacturer | W.L. GORE & ASSOCIATES, INC. |
| Report number | 2017233-2008-00063 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-19 |
| Report source | Health Professional, Company representation |
| Narrative | AS 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 |
| Source | openFDA MAUDE (device adverse events) |
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