EVOLUT PRO PLUS VALVE Adverse Event — Death (MDR 2025587-2020-01474)
EVOLUT PRO PLUS VALVE Adverse Event — Death (MDR 2025587-2020-01474) 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 | 2025587-2020-01474 |
| Event type | Death |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT ONE DAY FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT DIED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS BI-VENTRICULAR HEART FAILURE, RELATED TO COMPLICATIONS DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THAT PUT EXTRA STRESS ON THE PATIENT'S HEART. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. UPDATED: B2, H6 MEDTRONIC IS |
| Source | openFDA MAUDE (device adverse events) |
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