ENVEO PRO DELIVERY SYSTEM Adverse Event — Malfunction (MDR 2025587-2020-01433)
ENVEO PRO DELIVERY SYSTEM Adverse Event — Malfunction (MDR 2025587-2020-01433) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ENVEO PRO DELIVERY SYSTEM; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: MEDTRONIC HEART VALVES DIVISION.
| Device | ENVEO PRO DELIVERY SYSTEM |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | MEDTRONIC HEART VALVES DIVISION |
| Report number | 2025587-2020-01433 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | CONCLUSION: A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE DELIVERY CATHETER SYSTEM (DCS) LOT AND THERE WERE NO CORRELATIONS / ISSUES IDENTIFIED REGARDING MANUFACTURING. THE DEVICE WAS MANUFACTURED PER APPROVED AND RELEASED MANUFACTURING PROCESSES. THE DEVICE MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. CAPSULE BUCKLE CAN OCCUR DUE TO EXCESSIVE COMP |
| Source | openFDA MAUDE (device adverse events) |
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