BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM REGENT HEART VALVE W/FLEX CUFF

    MDR report key: 2152977 · Received June 17, 2011

    Report

    Report Number
    2648612-2011-00050
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE (B)(6), PATIENT, WITH A BSA OF (B)(6) UNDERWENT A MINIMALLY INVASIVE AVR. THE PATIENT'S ANNULUS AND AORTA WERE HEAVILY CALCIFIED. THE SURGEON DEBRIDED THE ANNULUS AND THIS VALVE WAS PLACED W/O DIFFICULTY. THE PATIENT WAS UNABLE TO COME OFF PUMP AND THE LEFT VENTRICLE WAS OBSERVED TO BE NOT MOVING BY ECHO. THE SURGEON PERFORMED A LEFT CORONARY ARTERY BYPASS AND THE PATIENT WAS STILL UNABLE TO COME OFF BYPASS. AN IABP WAS PLACED WITH LITTLE SUPPORT BECAUSE THE PATIENT'S DIASTOLIC PRESSURE WAS 19MMHG. THE PATIENT EXPIRED. THE SURGEON THOUGHT A PIECE OF PLAQUE WENT DOWN THE LEFT MAIN CORONARY ARTERY OR THAT THE PATIENT WAS NOT PROTECTED ADEQUATELY BY CARDIOPLEGIA. THE PHYSICIAN DID NOT BELIEVE THE EVENT WAS DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE W/FLEX CUFF REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC (CS) 19AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| R