BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 2890264 · Received December 29, 2012

    Report

    Report Number
    2015691-2012-18974
    Event Type
    Injury
    Date Received
    December 29, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD = THE DEVICE REMAINS IMPLANTED; NO PRODUCT RETURN. TRANSCATHETER VALVE IMPLANTATION INSIDE A DEGENERATED BIOPROSTHETIC VALVE ("VALVE IN VALVE", VIV) IS A LESS-INVASIVE ALTERNATIVE APPROACH. STENOSIS OF AN IMPLANTED VALVE CAUSES THE HEART TO WORK HARDER TO EJECT BLOOD FROM THE VENTRICLE AND CAN BE, DEPENDING ON THE SEVERITY, AN INDICATION FOR VALVE REPLACEMENT. THERE ARE MULTIPLE ETIOLOGIES FOR BIOPROSTHETIC VALVE STENOSIS SUCH AS CALCIFICATION, HOST TISSUE GROWTH... ETC. WITHOUT ADDITIONAL INFORMATION OR DEVICE RETURN AND EVALUATION, THE TYPE OF FAILURE CANNOT BE DETERMINED OR CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A EDWARDS BIOPROSTHETIC 23MM VALVE PRESENTED SYMPTOMS OF SEVERE AORTIC STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 11 YEARS AND WAS BEING EVALUATED FOR A POSSIBLE TRANSCATHETER VALVE IN VALVE PROCEDURE (TAVR). THE TAVR WAS SUCCESSFULLY PERFORMED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R