BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 4170961 · Received October 14, 2014

    Report

    Report Number
    2015691-2014-02413
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 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

    MODEL 6650: THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED. WITHOUT RETURN OF THE DEVICE, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. TRENDS ARE MONITORED ON A (B)(4) BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS HAS LEARNED OF A 23MM TRANSCATHER AORTIC VALVE-IN-VALVE INTERVENTION WHICH WAS PERFORMED APPROXIMATELY 15 YEARS AND EIGHT (8) MONTHS AFTER IMPLANT. THE REASON FOR THE INTERVENTION WAS DUE TO SEVERE AORTIC REGURGITATION SECONDARY TO CALCIFICATION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650824 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention