BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 3870799 · Received June 12, 2014

    Report

    Report Number
    2015691-2014-01378
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LEARNED THAT THIS DEVICE WAS EXPLANTED DUE TO DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD), OR DEGENERATION, IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE SPECIFIC NATURE OF THIS DEGENERATION CANNOT BE CONFIRMED WITHOUT THE SUBJECT DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THIS EVENT. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EDWARDS VALVE. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    AS REPORTED, THIS PATIENT REQUIRED A VALVE-IN-VALVE PROCEDURE AFTER APPROXIMATELY 9-10 YEARS (EXACT IMPLANT DATE IS UNKNOWN) WITHIN AN EXISTING EDWARDS BIOPROSTHETIC VALVE. THE REASON FOR REDO-AVR IS UNKNOWN. THE PATIENT REPORTED TO HAVE A "RARE DISEASE" AND COULD NOT UNDERGO SURGICAL VALVE REPLACEMENT. A TRANSCATHETER HEART VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT IS REPORTED AS STABLE. NO OTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347629 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R