EDWARDS SAPIEN 3 ULTRA VALVE Adverse Event — Malfunction (MDR 2015691-2020-11701)
EDWARDS SAPIEN 3 ULTRA VALVE Adverse Event — Malfunction (MDR 2015691-2020-11701) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EDWARDS SAPIEN 3 ULTRA VALVE; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: EDWARDS LIFESCIENCES.
| Device | EDWARDS SAPIEN 3 ULTRA VALVE |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | EDWARDS LIFESCIENCES |
| Report number | 2015691-2020-11701 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE VALVE WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. A REVIEW OF IMAGERY PROVIDED SHOWED THE FOLLOWING: ONE (1) STRUT WAS PUNCTURED THROUGH THE SHEATH, AND SEVERAL PROTRUDED SPOTS ON STRAIN RELIEF OF SHEATH. OBSERVED TORTUOSITY IN ACCESS VESSEL AND MLD (MINIMUM LUMEN DIAMETER) IS GREATER THAN 5.5MM. DUE TO THE UNAVAILABILITY OF THE DEVICE, NO POTENTIAL MANUFACTURING NONCONFORMANCE WA |
| Source | openFDA MAUDE (device adverse events) |
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