MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26 9600LDS26A manufactured by Edwards Lifesciences Llc.
[141463341]
During transcatheter aortic valve replacement (tavr) procedure, the sapien 3 valve and delivery system were across the annulus; ready for placement of the device when the balloon was inflated, it was noticed (on pull back) that there was blood into the inflation device. Balloon would not inflate, so the system was removed and replaced with a new one. It was noted that the balloon was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8499394 |
| MDR Report Key | 8499394 |
| Date Received | 2019-04-10 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-27 |
| Report Date | 2019-03-04 |
| Date Reported to FDA | 2019-03-04 |
| Date Reported to Mfgr | 2019-04-10 |
| Date Added to Maude | 2019-04-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-04-10 |
| Model Number | 9600LDS26 |
| Catalog Number | 9600LDS26A |
| Lot Number | 61757101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Brand Name | EDWARDS COMMANDER DELIVERY SYSTEM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2019-04-10 |
| Model Number | 9600LDS26 |
| Catalog Number | 9600LDS26A |
| Lot Number | 61757101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-04-10 |