BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM REGENT HEART VALVE W/FELX CUFF

    MDR report key: 1051692 · Received May 23, 2008

    Report

    Report Number
    2648612-2008-00015
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT UNDERWENT MITRAL VALVE REPLACEMENT IN 2007. IN 2008, THE PT'S INR WAS <1.8 AND IN TWO MONTHS LATER, THE MOVEMENT OF ONE LEAFLET WAS OBSERVED TO BE DYSFUNCTIONAL. THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE FROM ANOTHER MFR IN MAY. WHITE THROMBUS WAS OBSERVED IN THE RECESSED PIVOT AREAS OF THE EXPLANTED VALVE. THE SURGEON BELIEVES THE LOW INR WAS RELATED TO THE THROMBUS FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE W/FELX CUFF REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. 23AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R