SAPIEN, 23MM Adverse Event — Injury (MDR 2015691-2020-11716)
SAPIEN, 23MM Adverse Event — Injury (MDR 2015691-2020-11716) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SAPIEN, 23MM; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: EDWARDS LIFESCIENCES.
| Device | SAPIEN, 23MM |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | EDWARDS LIFESCIENCES |
| Report number | 2015691-2020-11716 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141. |
| Source | openFDA MAUDE (device adverse events) |
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