MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-19 for EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS 9600LDS23 manufactured by Edwards Lifesciences Llc.
[130791648]
During insertion of edwards commander tavr delivery system there was difficulty with advancing the catheter. After the catheter was inserted and just distal of the tip of the sheath the valve was advanced onto the balloon. It appeared that the delivery system was not in far enough to allow adequate positioning of the balloon. Providers attempted to advance the catheter in a few more centimeters before attempting to mount the valve onto the balloon. After these maneuvers were performed the valve was advanced across the aortic valve at which time it was noted that there was a spring coil in the delivery system that looked to be in the wrong position. It was decided that this was a potential device malfunction and the delivery system and valve were removed from the aorta and aortic valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8178594 |
| MDR Report Key | 8178594 |
| Date Received | 2018-12-19 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-10-31 |
| Report Date | 2018-11-15 |
| Date Reported to FDA | 2018-11-15 |
| Date Reported to Mfgr | 2018-12-19 |
| Date Added to Maude | 2018-12-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS COMMANDER DELIVERY SYSTEM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2018-10-31 |
| Model Number | 9600LDS |
| Catalog Number | 9600LDS23 |
| Lot Number | 61476610 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |