BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3885091 · Received June 19, 2014

    Report

    Report Number
    2015691-2014-01419
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS VALVE WAS REPLACED DUE TO AORTIC STENOSIS. MANY FACTORS CAN CONTRIBUTE TO THE ONSET OF BIOPROSTHETIC VALVE STENOSIS, INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. THERE IS CURRENTLY INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. IT APPEARS THAT PATIENT COMORBIDITIES MAY HAVE CONTRIBUTED TO THE PATIENT'S STENOSIS. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A QUALITY DEFICIENCY RELATED TO THE EDWARDS VALVE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT TAVR WITHIN AN EXISTING EDWARDS BIOPROSTHETIC VALVE (VALVE-IN-VALVE). THE ORIGINAL VALVE WAS IMPLANTED IN 2010; IMPLANT DURATION APPROXIMATELY FOUR (4) YEARS. THE PATIENT WAS NOTED TO HAVE MULTIPLE COMORBIDITIES, INCLUDING: SEVERE PULMONARY HYPERTENSION; SEVERE LUNG DISEASE. AORTIC STENOSIS WAS INDICATED. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361341 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R