EVOLUT PRO PLUS VALVE Adverse Event — Injury (MDR 2025587-2020-01497)
EVOLUT PRO PLUS VALVE Adverse Event — Injury (MDR 2025587-2020-01497) 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 | 2025587-2020-01497 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | IN ACCORDANCE WITH MODIFICATIONS TO SUMMARY REPORTING REGISTRY EXEMPTION E2014038 RECEIVED ON JUNE 2, 2020, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE STS/ACC TVT REGISTRY FOR THE COREVALVE SYSTEM. THE TVT REGISTRY SUBSEQUENTLY REMOVED THE FOLLOWING DATA: ONE EVENT OF RUPTURE. THE TOTAL EVENTS ARE UPDATED TO 1. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER |
| Source | openFDA MAUDE (device adverse events) |
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