FDA Adverse Event
Injury
Summary report: N
SJM AORTIC VALVED GRAFT PROSTHESIS
MDR report key: 2181220
·
Received July 22, 2011
Report
- Report Number
- 2126673-2011-00005
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 22, 2011
- Manufacturer
- ST. JUDE MEDICAL, INC. (CS-LILLEHEI)
- Product Code
- LWQ
- PMA / PMN Number
- P810002S27
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE VALVE WAS FUNCTIONING FINE UNTIL TWELVE YEARS POSTOPERATIVELY, WHEN THE PATIENT UNDERWENT AN MRI SCAN. DURING THE PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN. AN ECHO WAS CONDUCTED AND THE VALVE WAS OBSERVED TO BE MALFUNCTIONING. THE VALVE WAS EXPLANTED AND DURING THE EXPLANT PROCEDURE, THE SEWING CUFF WAS FOUND TO BE DEHISCED AND A FRACTURED LEAFLET WAS OBSERVED. THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 21 MM EPIC VALVE (MODEL AND SN UNKNOWN) SEWN ONTO A 24MM VALSALVA CONDUIT FROM ANOTHER MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM AORTIC VALVED GRAFT PROSTHESIS | AORTIC VALVED GRAFT | LWQ | ST. JUDE MEDICAL, INC. (CS-LILLEHEI) | 23CAVG-404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |