MAUDE MDR 50941437
- MDR report key
- 50941437
- Report number
- 9617601-2026-05864
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-08-18
- Date received
- 2026-09-30
- Adverse event
- 1
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 1
- Initial report to FDA
- 0
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 353652 | Medtronic Transcatheter Valve | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | Medtronic Mexico S. De R.L. De CV | NPT | MDT-TRANS VALVE | MDT-TRANS VALVE | | | | | | N |
| 418188 | Medtronic Transcatheter Valve | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | Medtronic Mexico S. De R.L. De CV | NPT | MDT-TRANS VALVE | MDT-TRANS VALVE | | | | | | N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-09-30 | 0 | L; H; R |
Event Narratives#
No narrative records found.