FDA Adverse Event
Other
Summary report: N
ATS 3F AORTIC BIOPROSTHESIS
MDR report key: 1562874
·
Received December 14, 2009
Report
- Report Number
- 2031780-2009-00011
- Event Type
- Other
- Date Received
- December 14, 2009
- Date of Event
- October 20, 2009
- Report Date
- November 11, 2009
- Manufacturer
- ATS MEDICAL, INC.
- Product Code
- LWR
- PMA / PMN Number
- P060025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD - VALVE BEING RETURNED TO CONTRACT PATHOLOGY LAB FOR EVALUATION.
Description of Event or Problem · 1
REPORTEDLY, THE VALVE WAS EXPLANTED DUE TO INSUFFICIENCY. DOCUMENTED WITH ECHOCARDIOGRAPHY. PARAVALVULAR LEAK (COMPLETE RIGHT CORONARY LEAFLET). AT EXPLANT, THE DOCTOR REPORTED THAT THE VALVE WAS IN GOOD CONDITION; SUTURES WERE INTACT. REPLACED WITH A MITROFLOW 23MM. NO PT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATS 3F AORTIC BIOPROSTHESIS | ATS 3F AORTIC BIOPROSTHESIS | LWR | ATS MEDICAL, INC. | 1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | RIFAMPICIN| VANCOMYCIN| IMPLANT -| GENTAMICIN| PT WAS TREATED WITH ANTIBIOTICS FOLLOWING INITIAL |