BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 3131919 · Received May 29, 2013

    Report

    Report Number
    2015691-2013-20184
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COPY OF THE PATIENT'S OP REPORT WAS RECEIVED WHICH SUPPORTS THE ORIGINAL REPORT OF ENDOCARDITIS. TEE DEMONSTRATED MITRAL VALVE DEHISCENCE FROM THE ANNULUS. MITRAL VALVE INSUFFICIENCY WAS ALSO NOTED. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. POST-PUMP TEE REVEALED A WELL-SEATED VALVE WITH NO PERIVALVULAR LEAKS. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED WITHOUT THE SAMPLE DEVICE, IT APPEARS THAT THE INSUFFICIENCY AND DEHISCENCE WERE LIKELY CAUSED BY THE INFECTED VALVE. THERE IS NO CHANGE IN THE ORIGINAL CONCLUSION OF THIS CASE.

    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. UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6 YEARS DUE TO PROSTHETIC VALVE ENDOCARDITIS. THE SURGEON INDICATED THAT THERE WAS NO MALFUNCTION OF THE EXPLANTED VALVE. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236266 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R