FDA Adverse Event
Injury
Summary report: N
SJM REGENT HEART VALVE W/FLEX CUFF
MDR report key: 1132630
·
Received August 22, 2008
Report
- Report Number
- 2648612-2008-00026
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- August 17, 2008
- Report Date
- August 22, 2008
- Manufacturer
- ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED AFTER THE SURGEON IMPLANTED THE VALVE HE NOTICED THE LEAFLETS DID NOT OPEN CORRECTLY. HE ATTEMPTED TO ROTATE THE VALVE BUT WAS UNABLE TO DO SO, AND THEREFORE DECIDED TO REMOVE THE VALVE. UPON REMOVAL, THE SURGEON NOTICED A FRACTURE IN THE ORIFICE NEAR THE PIVOT AREA. IT WAS REPORTED THIS EXTENDED SURGERY TIME, BUT THE PT IS DOING WELL. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM REGENT HEART VALVE W/FLEX CUFF | REGENT ROTATABLE VALVE | LWQ | ST. JUDE MEDICAL PUERTO RICO, INC. (CS) | 19AGFN-756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |