EPIC SUPRA VALVE W/FLEXFIT Adverse Event — Malfunction (MDR 3001883144-2020-00034)
EPIC SUPRA VALVE W/FLEXFIT Adverse Event — Malfunction (MDR 3001883144-2020-00034) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EPIC SUPRA VALVE W/FLEXFIT; Generic name: HEART-VALVE, NON-ALLOGRAFT TISSUE; Manufacturer: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA).
| Device | EPIC SUPRA VALVE W/FLEXFIT |
|---|---|
| Generic name | HEART-VALVE, NON-ALLOGRAFT TISSUE |
| Manufacturer | ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) |
| Report number | 3001883144-2020-00034 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | AVR WITH A 19MM EPIC SUPRA VALVE W/FLEXFIT AND VENTRICULAR SEPTUM DEFECT (VSD) CLOSURE WERE PERFORMED ON THE PATIENT IN (B)(6) 2011. THE PATIENT PRESENTED AT THE HOSPITAL IN THE OUTPATIENT ON (B)(6) 2019, COMPLAINING OF SHORTNESS OF BREATH DURING EXERTION. PRESSURE GRADIENT INCREASE WAS CONFIRMED IN THE DETAILED EXAMINATION, AND THE PHYSICIAN SUSPECTED VALVE DYSFUNCTION. AN ECHOCARDIOGRAM BEFORE T |
| Source | openFDA MAUDE (device adverse events) |
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