FDA Adverse Event
Injury
Summary report: N
SJM EPIC STENTED PORCINE HEART VALVE
MDR report key: 2161838
·
Received July 8, 2011
Report
- Report Number
- 3001743903-2011-00046
- Event Type
- Injury
- Date Received
- July 8, 2011
- Report Date
- July 8, 2011
- Manufacturer
- ST JUDE MEDICAL BRASIL LTDA
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE VALVE WAS IMPLANTED AND AT DISCHARGE THE GRADIENT ACROSS THE VALVE WAS NORMAL AT 3 MMHG. SIX MONTHS POSTOPERATIVELY, THE GRADIENT WAS FOUND TO BE 14 MMHG ON ECHO. IT WAS REPORTED THE VALVE SEEMED TO BE ENGROSSED WITH PANNUS AND LEAFLET MOBILITY WAS LOW. THE PATIENT IS BEING HOSPITALIZED AND THE VALVE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM EPIC STENTED PORCINE HEART VALVE | STENTED TISSUE VALVE | LWR | ST JUDE MEDICAL BRASIL LTDA | E100-29M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization |