EDWARDS COMMANDER DELIVERY SYSTEM Adverse Event — Injury (MDR 2015691-2020-11714)
EDWARDS COMMANDER DELIVERY SYSTEM Adverse Event — Injury (MDR 2015691-2020-11714) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EDWARDS COMMANDER DELIVERY SYSTEM; Generic name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED; Manufacturer: EDWARDS LIFESCIENCES.
| Device | EDWARDS COMMANDER DELIVERY SYSTEM |
|---|---|
| Generic name | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Manufacturer | EDWARDS LIFESCIENCES |
| Report number | 2015691-2020-11714 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | ADDITIONAL INFORMATION: SECTION H6: EVALUATION CODES; SECTION H10: NARRATIVE TEXT. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT I |
| Source | openFDA MAUDE (device adverse events) |
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