BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART-VALVE, REPLACEMENT

    MDR report key: 3013887 · Received March 20, 2013

    Report

    Report Number
    2015691-2013-19610
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTATION OF A TRANSCATHERTER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. STENOSIS OF A BIOPROSTHETIC VALVE 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. NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH FIELD CLINICAL SPECIALIST (SALES) THAT AN (B)(6) MALE PATIENT UNDERWENT IMPLANTATION OF AN EDWARDS SAPIEN 26MM TRANSCATHETER VALVE INSIDE AN EXISTING PERIMOUNT VALVE, VALVE-IN-VALVE (VIV), DUE TO SEVERE AORTIC STENOSIS. PATIENT IS NOTED AS STABLE AT THE END OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115531 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R