BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1823233 · Received September 2, 2010

    Report

    Report Number
    2015691-2010-13996
    Event Type
    Death
    Date Received
    September 2, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS FOR REPORT ONLY. CUSTOMER LETTER WAS NOT REQUESTED. NO PRODUCT RETURN AS THE DEVICE REMAINS IMPLANTED. NO RECORD OF AUTOPSY WAS REPORTED. (B)(4) EXPLANTED DUE TO A PARAVALVULAR LEAK FOR WHAT APPEARED TO BE AN ANNULAR ABSCESS CAUSED BY INFECTIOUS ENDOCARDITIS. THIS WAS THE REPLACEMENT DEVICE. DHR HAS BEEN STARTED. X-RAY.

    Additional Manufacturer Narrative · 1

    THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NO ADDITIONAL INFORMATION IS FORTHCOMING. THE CUSTOMER REPORTED BEING UNABLE TO CONTROL THE "CARDIAC ARREST AND INFECTION AFTER THIS SURGERY." PROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF .67 MONTHS DUE TO CARDIAC ARREST. EVENT WAS DESCRIBED AS "UNABLE TO CONTROL THE CARDIAC ARREST AND INFECTION AFTER THIS SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 09B040

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R