BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3171549 · Received June 15, 2013

    Report

    Report Number
    2015691-2013-20359
    Event Type
    Injury
    Date Received
    June 15, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTATION OF A TRANSCATHETER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. REGURGITATION OF BIOPROSTHETIC VALVES CAN BE CAUSED BY VARIOUS MECHANISMS; WITHOUT RETURN OF DEVICE AND EVALUATION (REMAINS IMPLANTED), THE NATURE OF THIS FAILURE CANNOT BE IDENTIFIED OR EVALUATED. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH SEVERE REGURGITATION OF AN EDWARDS AORTIC BIOPROSTHETIC VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY 13 YEARS. THE PATIENT UNDERWENT AN IMPLANT OF AN EDWARDS TRANSCATHETER BIOPROSTHETIC AORTIC VALVE INSIDE OF THE SUBJECT BIOPROSTHESIS (VALVE IN VALVE). NO COMPLICATIONS REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272575 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Hospitalization| L| R