FREESTYLE AORTIC ROOT BIOPROSTHESIS Adverse Event — Injury (MDR 2025587-2020-01477)
FREESTYLE AORTIC ROOT BIOPROSTHESIS Adverse Event — Injury (MDR 2025587-2020-01477) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FREESTYLE AORTIC ROOT BIOPROSTHESIS; Generic name: HEART-VALVE, NON-ALLOGRAFT TISSUE; Manufacturer: MEDTRONIC HEART VALVES DIVISION.
| Device | FREESTYLE AORTIC ROOT BIOPROSTHESIS |
|---|---|
| Generic name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Report number | 2025587-2020-01477 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | NO PRODUCT WAS RETURNED. CONCLUSION: 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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