SJM TRIFECTA VALVE Adverse Event — Injury (MDR 3008452825-2020-00215)
SJM TRIFECTA VALVE Adverse Event — Injury (MDR 3008452825-2020-00215) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SJM TRIFECTA VALVE; Generic name: HEART-VALVE, NON-ALLOGRAFT TISSUE; Manufacturer: ST. JUDE MEDICAL, COSTA RICA LTDA.
| Device | SJM TRIFECTA VALVE |
|---|---|
| Generic name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Report number | 3008452825-2020-00215 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | AN EVENT OF VALVE REPLACEMENT DUE TO STENOSIS, VALVE DYSFUNCTION, AND THE LEAFLETS OF THE VALVE BEING CALCIFIED WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED |
| Source | openFDA MAUDE (device adverse events) |
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