BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3800863 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01057
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    November 24, 2009
    Report Date
    April 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENOTIC AND REGURGITANT BIOPROSTHETIC VALVE. ADDITIONAL MANUFACTURER NARRATIVE: IT WAS LEARNED THAT THIS PATIENT HAD A STENOTIC AND REGURGITANT BIOPROSTHETIC VALVE. MANY FACTORS CAN CONTRIBUTE TO THE ONSET BIOPROSTHETIC STENOSIS AND REGURGITATION, INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONFIRM THE ROOT CAUSE OF THIS EVENT. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A QUALITY DEFICIENCY RELATED TO THE EDWARDS VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    TRANSCATHETER VALVE-IN-VALVE IMPLANTATION FOR FAILED BIOPROSTHETIC HEART VALVES STUDY: IT WAS IDENTIFIED THROUGH REVIEW OF THIS LITERATURE THAT THIS PATIENT EXPERIENCED AORTIC STENOSIS AND REGURGITATION OF THEIR EDWARDS BIOPROSTHETIC VALVE AFTER AN IMPLANT DURATION OF APPROXIMATELY 25 YEARS. THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277301 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R