FDA Adverse Event
Summary report: N
MOSIAC ULTRA PORCINE
MDR report key: 1359870
·
Received March 31, 2009
Report
- Report Number
- 1359870
- Date Received
- March 31, 2009
- Date of Event
- December 9, 2008
- Report Date
- March 30, 2009
- Manufacturer
- MEDTRONIC CARDIAC SURGERY
- Product Code
- LWR
- Report Source
- User Facility report
- Reporter Location
- ND, US
Narratives
Description of Event or Problem · 1
PERSISTENT AORTIC STENOSIS LEADING TO PERSISTENT HEART FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOSIAC ULTRA PORCINE | VALVE, AORTIC | LWR | MEDTRONIC CARDIAC SURGERY | MOSIAC 21MM | 305U21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |