MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for EDWARDS SAPIEN TRANSCATHETER HEART VALVE 9000TFX26 N/A manufactured by Edwards Lifesciences.
| Report Number | 2015691-2019-04413 |
| MDR Report Key | 9378054 |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2019-11-12 |
| Device Manufacturer Date | 2014-04-14 |
| Date Added to Maude | 2019-11-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FRANCES PRESTON |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492505190 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDWARDS SAPIEN TRANSCATHETER HEART VALVE |
| Generic Name | TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR |
| Product Code | NPR |
| Date Received | 2019-11-26 |
| Model Number | 9000TFX26 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2016-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-26 |