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..
| Device | GORE EXCLUDER AAA ENDOPROSTHESIS |
|---|---|
| Generic name | ENDOVASCULAR GRAFT SYSTEM |
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
| Report number | 2953161-2008-00036 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-18 |
| Report source | Health Professional, Company representation |
| Narrative | IN 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. |
| Source | openFDA MAUDE (device adverse events) |
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