BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 2890283 · Received December 29, 2012

    Report

    Report Number
    2015691-2012-18975
    Event Type
    Injury
    Date Received
    December 29, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 28, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE STILL IMPLANTED, NO PRODUCT RETURN. THE VALVE IN VALVE PROCEDURE WAS SUCCESSFULLY PERFORMED ON (B)(6) 2012. 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 21MM AORTIC VALVE PRESENTED SYMPTOMS OF AORTIC STENOSIS AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS AND WAS BEING EVALUATED FOR A POSSIBLE VALVE IN VALVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R