FDA Adverse Event
Injury
Summary report: N
SJM BIOCOR STENTED PORCINE VALVE W/FLEXFIT SYSTEM
MDR report key: 2230492
·
Received August 12, 2011
Report
- Report Number
- 3001743903-2011-00055
- Event Type
- Injury
- Date Received
- August 12, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 12, 2011
- Manufacturer
- ST. JUDE MEDICAL BRASIL LTDA.
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SEVERE REGURGITATION WAS OBSERVED ON ECHO AND THE PT HAD GONE INTO HEART FAILURE AS A RESULT; THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 29 MM SJM MECHANICAL VALVE IN THE TRICUSPID POSITION. DURING THE EXPLANT PROCEDURE, PANNUS AROUND THE EDGES OF THE VALVE WAS DEBRIDED. THE PT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM BIOCOR STENTED PORCINE VALVE W/FLEXFIT SYSTEM | STENTED TISSUE VALVE | LWR | ST. JUDE MEDICAL BRASIL LTDA. | B100-33M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| R |