BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRAL VALVE

    MDR report key: 1951331 · Received December 13, 2010

    Report

    Report Number
    1951331
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SEPTAL MYOMECTOMY AND MITRAL VALVE REPLACEMENT USING A 27-MILLIMETER ST. JUDE MECHANICAL VALVE APPROXIMATELY FIVE MONTHS AGO. THE PATIENT WAS READMITTED TO THE HOSPITAL ON ONE MONTH AFTER THE SURGERY WITH BREATHLESSNESS. WORKUP DURING THAT HOSPITALIZATION LED TO THE DISCOVERY OF PROSTHETIC VALVE DYSFUNCTION AND TEN DAYS LATER PATIENT UNDERWENT A REDO STERNOTOMY AND REPLACEMENT WITH A SIMILAR 27-MILLIMETER ST. JUDE MECHANICAL PROSTHESIS. A ONE-CENTIMETER THROMBUS VS. VEGETATION WAS NOTED TO BE ADHERENT TO THE CENTER POST OF BOTH LEAFLETS OF THE EXPLANTED VALVE. THIS WAS SENT FOR CULTURE WHICH WAS FOUND TO BE NEGATIVE FOR BACTERIA, FUNGUS, OR OTHER ORGANISM. SUBSEQUENTLY, THE PATIENT WAS READMITTED TO THE HOSPITAL TWO MONTHS AFTER SECOND REPLACEMENT WITH PROSTHETIC VALVE THROMBOSIS AND UNDERWENT A SECOND REDO STERNOTOMY AND THE MITRAL VALVE WAS REPLACED WITH A 27-MILLIMETER CARPENTIER-EDWARDS BIOPROSTHESIS. THE PATIENT ALSO UNDERWENT EVALUATION FOR HYPERCOAGULABILITY AND PLATELET ABNORMALITIES. THE PATIENT HAS BEEN DOING RELATIVELY WELL SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITRAL VALVE HEART VALVE, MECHANICAL #2 LWQ ST. JUDE MEDICAL 27MJ501 *
    2 MITRAL VALVE HEART VALVE, MECHANICAL #1 LWQ ST. JUDE MEDICAL 27MJ501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR