BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1668377 · Received April 23, 2010

    Report

    Report Number
    2031780-2010-00005
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    March 19, 2010
    Report Date
    March 22, 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

    VALVE HAS BEEN 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 VALVE WAS EXPLANTED AT IMPLANT DUE TO SEVERE AORTIC REGURGITATION BETWEEN THE COMMISSURES. AT EXPLANT, THE 3F VALVE APPEARED TO BE IN GOOD CONDITION. IT WAS REPLACED WITH AN EDWRDS MAGNA 25MM VALVE. NO PT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT. PT IS REPORTEDLY DOING FINE. DOCTOR NOTED THAT THE ECHO SHOWED A SIGNIFICANT JET BETWEEN THE LEFT CORONARY CUSP AND THE NON-CORONARY CUSP. HE FEELS THAT WHEN HE SUTURED THE VALVE IN PLACE (RUNNING THE SUTURE), HE MUST HAVE WENT OUT OF PLANE, THEREBY CAUSING THE LEAK.

    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 62 YR Required Intervention