BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1619850 · Received February 23, 2010

    Report

    Report Number
    2031780-2010-00001
    Event Type
    Other
    Date Received
    February 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 8, 2010
    Manufacturer
    ATS MEDICAL INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP DISCARDED VALVE AT TIME OF EXPLANT. 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, 3F VALVE WAS EXPLANTED SOMETIME IN (B)(6) OF 2010, AFTER APPROX 8 MONTHS IMPLANT DURATION, DUE TO ENDOCARDITIS. THE DOCTOR DOES NOT ATTRIBUTE THE ENDOCARDITIS TO THE VALVE, BUT RATHER, TO THE PT. PT IS REPORTEDLY DOING FINE.

    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 63 YR Required Intervention