FDA Adverse Event
Injury
Summary report: N
ATS OPEN PIVOT BILEAFLET HEART VALVE
MDR report key: 1352129
·
Received March 23, 2009
Report
- Report Number
- 2134151-2009-00003
- Event Type
- Injury
- Date Received
- March 23, 2009
- Date of Event
- February 4, 2008
- Report Date
- February 5, 2009
- Manufacturer
- ATS MEDICAL, INC.
- Product Code
- LWQ
- PMA / PMN Number
- P990046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
VALVE NOT YET RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE VALVE WAS REVIEWED. THE VALVE WAS BUILT TO SPECIFICATIONS, AND PASSED ALL TESTS AND INSPECTIONS. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE VALVE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. VALVE NOT YET RETURNED FOR EVALUATION.
Description of Event or Problem · 1
REPORTEDLY, THE VALVE WAS EXPLANTED AFTER APPROXIMATELY 2 MONTHS IMPLANT DURATION DUE TO BLOCKAGE OF ONE LEAFLET. VALVE WAS REPLACED. PT IS REPORTEDLY STABILIZED AND DOING SATISFACTORY. ACCORDING TO THE CARDIAC SURGEON WHO PERFORMED THE EXPLANT, ONE LEAFLET DID NOT APPEAR TO BE REACTING FREELY. NO THROMBOSIS WAS ENCOUNTERED. NOTHING SUSPICIOUS THAT MIGHT PREVENT THE LEAFLETS TO MOVE FREELY WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATS OPEN PIVOT BILEAFLET HEART VALVE | ATS STANDARD MITRAL VALVE | LWQ | ATS MEDICAL, INC. | 501DM27 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |