BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 3191538 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20433
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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 SEVERE STENOSIS CANNOT BE IDENTIFIED OR EVALUATED. STENOSIS MAY BE DUE TO CALCIFIC TISSUE DEGENERATION, NON CALCIFIC TISSUE DEGENERATION, AND/OR NON-STRUCTURAL DYSFUNCTION. THERE IS 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 VIA CLINICAL AFFAIRS THAT A (B)(6) FEMALE PATIENT WAS DIAGNOSED WITH SEVERE STENOSIS OF AN EDWARDS AORTIC BIOPROSTHETIC VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY 8 YEARS. THE PATIENT UNDERWENT AN IMPLANT OF A TRANSCATHETER HEART VALVE INSIDE THE SUBJECT STENOSED VALVE (VALVE IN VALVE PROCEDURE), AND REPORTED AS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290053 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R