FDA Adverse Event
Injury
Summary report: N
SJM MASTERS SERIES COATED AORTIC VALVED GRAFT
MDR report key: 1924337
·
Received December 7, 2010
Report
- Report Number
- 2648612-2010-00072
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 5, 2010
- Report Date
- December 7, 2010
- Manufacturer
- ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED INTRAOPERATIVELY, THE SURGEON IMPLANTED THE DEVICE AND NOTICED LEAKAGE FROM WHERE THE GRAFT IS SEWN TO THE SEWING CUFF ON THE VALVE. THE LEAKAGE OCCURRED WHEN THE BLOOD FLOW WAS RESTARTED AFTER IMPLANTING THE VALVED GRAFT. THERE WAS SOME DIFFICULTY STOPPING THE LEAKAGE AND BLOOD PRODUCTS WERE ADMINISTERED. THE VALVED GRAFT REMAINS IMPLANTED AND THE PT IS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM MASTERS SERIES COATED AORTIC VALVED GRAFT | ROTATABLE VALVED GRAFT | LWQ | ST. JUDE MEDICAL PUERTO RICO, INC. (CS) | 23CAVGJ-514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |