FDA Adverse Event
Injury
Summary report: N
TORONTO STENTLESS PORCINE VALVE
MDR report key: 1180478
·
Received September 26, 2008
Report
- Report Number
- 8020430-2008-00007
- Event Type
- Injury
- Date Received
- September 26, 2008
- Date of Event
- July 28, 2008
- Report Date
- September 26, 2008
- Manufacturer
- ST. JUDE MEDICAL CANADA, INC.
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SJM RECEIVED INFO INDICATING THE VALVE HAD BEEN REPLACED. THE SURGEON INDICATED THE PT PRESENTED WITH THIS VALVE SHOWING DEGENERATION REQUIRING RE-OPERATION AS WELL AS CORONARY BYPASS GRAFTS. THE SURGEON STATED THE FINDINGS AT EXPLANT WERE CONSISTENT WITH VALVE DEGENERATION WITH NO ASSOCIATED INFECTION. THE VALVE WAS REPLACED WITH A SMALLER 21 MM SJM MECHANICAL VALVE (MODEL 21AECJ-502). ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TORONTO STENTLESS PORCINE VALVE | TORONTO STENTLESS VALVE | LWR | ST. JUDE MEDICAL CANADA, INC. | SPA-101-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |