BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MASTERS SERIES VALVE EXPANDED CUFF

    MDR report key: 5080592 · Received September 16, 2015

    Report

    Report Number
    2648612-2015-00020
    Event Type
    Death
    Date Received
    September 16, 2015
    Date of Event
    August 29, 2015
    Report Date
    September 1, 2015
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A 29MM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED AND THE POST-OP ECHO SHOWED NORMAL VALVE FUNCTION. IN (B)(6) 2015, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A TWO-DAY HISTORY OF DYSPNEA. ON (B)(6) 2015, HIS INR MEASURED 1.8. ON (B)(6) 2015, HIS INR MEASURED 2.38 AND A FOLLOW-UP ECHO REVEALED AN IMPEDED MITRAL VALVE WITH A PEAK GRADIENT OF 22MMHG AND A MEAN GRADIENT OF 10MMHG IN THE PRESENCE OF SEVERE LV DYSFUNCTION. THE PATIENT EXPIRED LATER THAT DAY IN THE ICU DUE TO SEVERE LV DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612914 SJM MASTERS SERIES VALVE EXPANDED CUFF HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 29MECJ-502 3500198

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death