BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 2974394 · Received February 22, 2013

    Report

    Report Number
    2015691-2013-19356
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P870056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. ADDITIONALLY, THE SURGEON HAS INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION. THE INFECTION SOURCE WAS PROVIDED AS ENTEROCOCCUS.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 MONTHS DUE TO PROSTHETIC VALVE ENDOCARDITIS. THE SURGEON INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION. THE INFECTION SOURCE WAS PROVIDED AS ENTEROCOCCUS. THE EXPLANTED DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78191 CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6625 R-11E1840

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R