PERCEVAL SUTURELESS AORTIC HEART VALVE Adverse Event — Injury (MDR 1718850-2020-01071)
PERCEVAL SUTURELESS AORTIC HEART VALVE Adverse Event — Injury (MDR 1718850-2020-01071) 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 | 1718850-2020-01071 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Narrative | A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE PERCEVAL VALVE (MODEL PVS25, SN (B)(4)) HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. BASED ON THE INFORMATION AVAILABLE ON THE DATABASE, THERE IS NO INDICATION OF VALVE RE-INTERVENTION. AS SUCH, SINCE THE DEVICE IS NOT A |
| Source | openFDA MAUDE (device adverse events) |
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