MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV) 9600TFX 9600TFX23A manufactured by Edwards Lifesciences Llc.
[174869769]
The aneurysm perforated. The valve got caught in the tissue and the valve was unable to be removed. This impacted the patient's ability to receive alternate treatments. Unknown contribution to patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9586115 |
| MDR Report Key | 9586115 |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-10-31 |
| Report Date | 2019-12-23 |
| Date Reported to FDA | 2019-12-23 |
| Date Reported to Mfgr | 2020-01-14 |
| Date Added to Maude | 2020-01-14 |
| 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 | 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 SAPIEN 3 TRANSCATHETER HEART VALVE (THV) |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2020-01-14 |
| Model Number | 9600TFX |
| Catalog Number | 9600TFX23A |
| 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 | 2020-01-14 |