GORE TEX VASCULAR GRAFT (LINED) Adverse Event — Injury (MDR 2017233-2008-00072)
GORE TEX VASCULAR GRAFT (LINED) Adverse Event — Injury (MDR 2017233-2008-00072) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GORE TEX VASCULAR GRAFT (LINED); Generic name: EPTFE VASCULAR PROSTHESIS; Manufacturer: W.L. GORE & ASSOCIATES, INC..
| Device | GORE TEX VASCULAR GRAFT (LINED) |
|---|---|
| Generic name | EPTFE VASCULAR PROSTHESIS |
| Manufacturer | W.L. GORE & ASSOCIATES, INC. |
| Report number | 2017233-2008-00072 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-19 |
| Report source | Foreign, Health Professional, Company representation |
| Narrative | THE PHYSICIAN IMPLANTED A GORE TEX VASCULAR GRAFT (LINED) IN 2007 FOR AV ACCESS. SEROUS LEAKAGE WAS REPORTED AT THE TOP OF THE LOOP OF THE GRAFT SHORTLY AFTER IMPLANT. IN 2007, THE PHYSICIAN REPLACED THE GRAFT DUE TO A SEROMA. ACCORDING TO THE PHYSICIAN THE HYPODERMAL TISSUE OR ADIPOSE OF THE PATIENT'S ARM AT THE IMPLANT SITE WAS NOT ENOUGH. |
| Source | openFDA MAUDE (device adverse events) |
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