EVOLUT PRO TRANSCATHETER AORTIC VALVE Adverse Event — Injury (MDR 2025587-2020-01467)
EVOLUT PRO TRANSCATHETER AORTIC VALVE Adverse Event — Injury (MDR 2025587-2020-01467) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EVOLUT PRO TRANSCATHETER AORTIC VALVE; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: MEDTRONIC HEART VALVES DIV
| Device | EVOLUT PRO TRANSCATHETER AORTIC VALVE |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Report number | 2025587-2020-01467 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE |
| Source | openFDA MAUDE (device adverse events) |
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