AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) Adverse Event — Malfunction (MDR 3007284313-2020-00121)
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) Adverse Event — Malfunction (MDR 3007284313-2020-00121) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT; Manufacturer: W.L. GORE &
| Device | AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) |
|---|---|
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Report number | 3007284313-2020-00121 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THE DEVICE WAS RETURNED TO GORE FOR AN ENGINEERING ANALYSIS AND SHOWED THE FOLLOWING: THE RETURNED GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM DEVICE WAS RETURNED TO GORE WITH THE GUIDEWIRE USED IN THE PROCEDURE STILL INSERTED IN THE CATHETER. THE DELIVERY CATHETER PRESENTED A KINK AT THE NOSE PIECE WHICH COULD POSSIBLY BE DUE TO THE SHIPPING OF THE DEVICE BACK TO THE GORE FAC |
| Source | openFDA MAUDE (device adverse events) |
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