EVOLUT PRO PLUS VALVE Adverse Event — Injury (MDR 2025587-2020-01464)
EVOLUT PRO PLUS VALVE Adverse Event — Injury (MDR 2025587-2020-01464) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EVOLUT PRO PLUS VALVE; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: MEDTRONIC HEART VALVES DIVISION.
| Device | EVOLUT PRO PLUS VALVE |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Report number | 2025587-2020-01464 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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