BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3061974 · Received April 16, 2013

    Report

    Report Number
    2015691-2013-19828
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. STENOSIS OF AN BIOPROSTHETIC VALVES IS DEPENDENT ON BOTH PATIENT FACTORS AND INTRINSIC PROPERTIES OF BIOPROSTHETIC VALVES. WITHOUT RETURN OF DEVICE, THE NATURE OF THE REPORTED STENOSIS LEADING TO THIS EXPLANT CANNOT BE IDENTIFIED OR EVALUATED. STENOSIS MAY BE DUE TO CALCIFIC TISSUE DEGENERATION, NON CALCIFIC TISSUE DEGENERATION, AND/OR NON-STRUCTURAL DYSFUNCTION. THE PROVIDED INFORMATION SUGGESTS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SALES THAT A PATIENT WITH AN EDWARDS AORTIC BIOPROSTHETIC VALVE WAS DIAGNOSED WITH AORTIC STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 14 YEARS, AND UNDERWENT AN IMPLANT OF A TRANSCATHETER VALVE INSIDE THE FAILING ONE. RECORDS INDICATE THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162368 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L