BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1546578 · Received November 17, 2009

    Report

    Report Number
    2031780-2009-00013
    Event Type
    Other
    Date Received
    November 17, 2009
    Date of Event
    November 4, 2009
    Report Date
    November 6, 2009
    Manufacturer
    ATS MEDICAL INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE DISCARDED AT HOSPITAL. 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, AN ATS 3F AORTIC VALVE WAS EXPLANTED DUE TO SEVERE AORTIC INSUFFICIENCY AS SEEN ON TRANSTHORACIC ECHO. DOCTOR REPORTED THAT THE TABS DID NOT APPEAR TO BE 120 DEGREES APART. THEY WERE NOT EQUAL DISTENT. AT IMPLANT, THE INTRAOPERATIVE ECHO SHOWED MILD AORTIC INSUFFICIENCY. CARDIOLOGIST THOUGHT IT WAS OK. COUPLE OF DAYS LATER, DECIDED TO DO ANOTHER ECHO. VALVE WAS REPLACED WITH ANOTHER MFR'S STENTED VALVE. ATS VALVE WAS DISCARDED AT THE HOSPITAL. PT IS REPORTEDLY DOING FINE. DOCTOR REPORTED THAT THE QUALITY OF THE INTRAOPERATIVE ECHO WAS NOT VERY GOOD. IN ADDITION, THERE MAY HAVE BEEN SOME DILATATION IN THE AORTA. DOCTOR DOES NOT FEEL THAT THERE WAS ANYTHING WRONG WITH THE ATS VALVE. RATHER, IT WAS THE WAY IT MAY HAVE BEEN IMPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 UNK Required Intervention