FDA Adverse Event
Injury
Summary report: N
ATS OPEN PIVOT BILEAFLET HEART VALVE
MDR report key: 1185883
·
Received October 3, 2008
Report
- Report Number
- 2134151-2008-00002
- Event Type
- Injury
- Date Received
- October 3, 2008
- Date of Event
- August 26, 2008
- Report Date
- September 30, 2008
- Manufacturer
- ATS MEDICAL, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P990046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE WITHIN SPECIFICATION AND MET ALL ACCEPTANCE CRITERIA. THE SURGEON REPORTS THAT THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED. EVALUATION: ATS HAS NOT YET RECEIVED THE VALVE FROM THE HOSPITAL. IT IS EXPECTED TO BE RETURNED AND WILL BE EVALUATED AT THAT TIME.
Description of Event or Problem · 1
THE PHYSICIAN STATED THAT A MALE PATIENT WAS OPERATED ON FOR DOUBLE VALVE REPLACEMENT. AFTER COMING OFF CPB, THE PATIENT PRESSURES WERE NOT MAINTAINED WELL. INTRA OPERATIVE TEE SHOWED THAT THE AORTIC VALVE LEAFLETS WERE NOT CLOSING PROPERLY. AS THE PATIENT HEMODYNAMICS WERE NOT MAINTAINED, THE AORTIC VALVE WAS REPLACED WITH ANOTHER ATS AORTIC VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATS OPEN PIVOT BILEAFLET HEART VALVE | HEART VALVE MECHANICAL | LWQ | ATS MEDICAL, INC. | 501DA20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization | DVR REPLACEMENT ON THE SAME DAY |