PERCEVAL SUTURELESS AORTIC HEART VALVE Adverse Event — Injury (MDR 3005687633-2020-00120)
PERCEVAL SUTURELESS AORTIC HEART VALVE Adverse Event — Injury (MDR 3005687633-2020-00120) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PERCEVAL SUTURELESS AORTIC HEART VALVE; Generic name: TISSUE HEART VALVES; Manufacturer: SORIN GROUP ITALIA S.R.L..
| Device | PERCEVAL SUTURELESS AORTIC HEART VALVE |
|---|---|
| Generic name | TISSUE HEART VALVES |
| Manufacturer | SORIN GROUP ITALIA S.R.L. |
| Report number | 3005687633-2020-00120 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, STUDY |
| Narrative | THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE SURE AVR REGISTRY. ON (B)(6) 2014 A PATIENT RECEIVED A PERCEVAL PVS25 IN AORTIC POSITION. GOOD DEVICE FUNCTIONALITY IS RECORDED AT DISCHARGE AND IN THE YEARLY FOLLOW-UP VISITS UP TO (B)(6) 2017. THE MANUFACTURER WAS INFORMED ON THE FOLLOWING ADVERSE EVENT, WHICH OCCURRED ON (B)(6) 2018: STRUCTURAL VALVE DETERIORATION DESCRIBED AS LEAFLET STIF |
| Source | openFDA MAUDE (device adverse events) |
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