AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) Adverse Event — Injury (MDR 3007284313-2020-00116)
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) Adverse Event — Injury (MDR 3007284313-2020-00116) 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 & ASSO
| Device | AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3) |
|---|---|
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Report number | 3007284313-2020-00116 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | CONCOMITANT MEDICAL PRODUCTS: PLA360400/21339109 UDI: (B)(4); PLA360400J/20636477 UDI: (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK. |
| Source | openFDA MAUDE (device adverse events) |
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