BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATS OPEN PIVOT BILEAFLET HEART VALVE

    MDR report key: 1102905 · Received August 6, 2008

    Report

    Report Number
    2134151-2008-00001
    Event Type
    Death
    Date Received
    August 6, 2008
    Date of Event
    March 12, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE AND THE ROTATOR SUPPLIED WITH THE VALVE WERE DISCARDED AT THE HOSPITAL AND NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY 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 THERE WAS NO VALVE OR ROTATOR RETURNED FOR INVESTIGATION. THE DIFFICULTY ROTATING THE VALVE WAS NOT A DEFECT OF THE VALVE OR ROTATOR, BUT HE PHYSICIAN'S DECISION TO IMPLANT A VALVE THAT WAS TOO LARGE FOR THE PT. THE INSTRUCTIONS FOR USE (IFU) CONTAINS INFO FOR SIZING THE VALVE. THIS EVENT WAS RECENTLY CONSERVATIVELY RECLASSIFIED AS REPORTABLE.

    Description of Event or Problem · 1

    THE PHYSICIAN, STATED THAT THE VALVE WAS DIFFICULT TO ROTATE. THE PHYSICIAN'S QUESTIONNAIRE STATES THE PT WAS UNDERGOING A TRIPLE VALVE REPLACEMENT AND THE SURGEON HAD DIFFICULTY ROTATING A 31MM MITRAL, STANDARD VALVE. HE DETERMINED THAT THE VALVE MIGHT HAVE BEEN SIZED TOO LARGE AND IMPLANTED A 29MM INSTEAD. THE PT LATER EXPIRED. THE PT WAS VERY SICK WITH EXTENSIVE HYPERTROPHY. DURING THE PROCEDURE, THE SURGICAL STAFF CONTAMINATED THE ROTATOR THAT IS PROVIDED WITH THE VALVE, SO THE PHYSICIAN COULD NOT USE IT. HE TRIED TO ROTATE THE VALVE WITH OUR ROTATOR AND HEX HEAD INSTRUMENT, BUT HAD DIFFICULTY ROTATING THE VALVE. THE VALVE WAS TOO LARGE FOR THE PT SO THE PHYSICIAN OPTED FOR A SMALLER VALVE TO BE IMPLANTED.

    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. 500DM31

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ROTATOR AND HEX HEAD INSTRUMENT (MODEL 568)| ATS STANDARD MITRAL VALVE (MODEL 500DM29)