MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE 9750TFX26 9750TFX26A manufactured by Edwards Lifesciences Llc.
| Report Number | 8716062 |
| MDR Report Key | 8716062 |
| Date Received | 2019-06-20 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-10 |
| Report Date | 2019-04-24 |
| Date Reported to FDA | 2019-04-24 |
| Date Reported to Mfgr | 2019-06-20 |
| Date Added to Maude | 2019-06-20 |
| 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 ULTRA TRANSCATHETER HEART VALVE |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2019-06-20 |
| Model Number | 9750TFX26 |
| Catalog Number | 9750TFX26A |
| 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 | 1. Death; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2019-06-20 |