MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-09 for SAPIEN M3 VALVE 9680TFX29M manufactured by Edwards Lifesciences.
[175252588]
The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[175252589]
As reported by the m3 clinical trial, approximately 1 year and 3 months post procedure, echo showed severe mitral stenosis. The peak mitral velocity was 2. 43 m/s, and peak gradient was 23. 7mmhg and mean gradient was 14. 2 mmhg. No action was taken. The patient required hospitalization or prolongation of existing hospitalization. The outcome was not recovered/not resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10119 |
| MDR Report Key | 9572434 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2020-01-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | SAPIEN M3 VALVE |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2020-01-09 |
| Model Number | 9680TFX29M |
| Device Expiration Date | 2019-09-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization | 2020-01-09 |