EDWARDS COMMANDER DELIVERY SYSTEM, 26MM Adverse Event — Injury (MDR 2015691-2020-11711)
EDWARDS COMMANDER DELIVERY SYSTEM, 26MM Adverse Event — Injury (MDR 2015691-2020-11711) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EDWARDS COMMANDER DELIVERY SYSTEM, 26MM; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: EDWARDS LIFESCIENCES.
| Device | EDWARDS COMMANDER DELIVERY SYSTEM, 26MM |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | EDWARDS LIFESCIENCES |
| Report number | 2015691-2020-11711 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN |
| Narrative | THE COMMANDER DELIVERY SYSTEM WAS NOT RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. WITHOUT THE DEVICE RETURNED FOR EVALUATION, VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE UNABLE TO BE COMPLETED. NO PHOTO OR PROCEDURAL VIDEO WAS PROVIDED FOR EVALUATION. ALL INSPECTIONS ARE CONDUCTED ON 100% OF UNITS EXPECT FOR PRODUCT VERIFICATION (PV) TESTING. PER PROCEDURE, DURING THE |
| Source | openFDA MAUDE (device adverse events) |
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