FDA Adverse Event
Injury
Summary report: N
SJM EPIC SUPRA STENTED PORCINE HEART VALVE
MDR report key: 3181320
·
Received June 14, 2013
Report
- Report Number
- 3001743903-2013-00029
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- May 30, 2013
- Report Date
- June 4, 2013
- Manufacturer
- ST JUDE MEDICAL BRASIL LTDA.
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE INFORMATION PROVIDED TO SJM INDICATED THAT AORTIC VALVE WAS EXPLANTED DUE TO MARKED RECURRENT STENOSIS. AT EXPLANTS, PANNUS GROWTH WAS OBSERVED AT THE LEFT VENTRICULAR OUTGROWTH TRACT, EXTENDING INTO THE VALVE, WHICH CAUSED RESTRICTED LEAFLET MOVEMENT. THE VALVE WAS REPLACED WITH A 25MM PERIMOUNT VALVE (MODEL/SN: UNKNOWN), AND RESECTION OF SUBVALVULAR PANNUS TISSUE WAS PERFORMED. THE PATIENT WAS STABLE FOLLOWING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271221 | SJM EPIC SUPRA STENTED PORCINE HEART VALVE | STENTED TISSUE VALVE | LWR | ST JUDE MEDICAL BRASIL LTDA. | ESP100-23 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R |