FDA Adverse Event
Other
Summary report: N
ATS 3F AORTIC BIOPROSTHESIS
MDR report key: 1562868
·
Received December 14, 2009
Report
- Report Number
- 2031780-2009-00012
- Event Type
- Other
- Date Received
- December 14, 2009
- Date of Event
- October 1, 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE CONFIRMED THAT IT MET ALL SPECIFICATIONS AND PASSED ALL INSPECTIONS PRIOR TO RELEASE.
Description of Event or Problem · 1
REPORTEDLY, THE VALVE WAS EXPLANTED DUE TO INSUFFICIENCY. DOCUMENTED WITH ECHOCARDIOGRAPHY. AORTIC INSUFFICIENCY GRADE III. AT EXPLANT, THE DOCTOR REPORTED THAT THE VALVE WAS IN GOOD CONDITION. 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 | 62 YR | Required Intervention | PT ON CONTINUOUS ANTICOAGULANT THERAPY |