BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1709351 · Received May 25, 2010

    Report

    Report Number
    2031780-2010-00009
    Event Type
    Other
    Date Received
    May 25, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 30, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE IS BEING RETURNED TO CONTRACT PATHOLOGY LAB FOR ANALYSIS. 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 AORTIC BIOPROSTHESIS WAS EXPLANTED AFTER 5 YEARS, 7 MONTHS IMPLANT DURATION, DUE TO CARDIAC INSUFFICIENCY. AT EXPLANT IT WAS NOTED THAT 2 OF THE CUSPS WERE CALCIFIED. NO PERI-PROSTHETIC LEAK. IT WAS REPLACED WITH A SJM EPIC, SIZE 23MM. 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 77 YR Required Intervention