BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10.

    MDR report key: 4841990 · Received June 12, 2015

    Report

    Report Number
    2015691-2015-01386
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    February 27, 2009
    Report Date
    April 13, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS® DURAFLEX® LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL# 6625-LP, PMA# P870077. DEVICE WAS NOT RETURNED. \ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. MITRAL REGURGITATION (MR) IN BIOPROSTHETIC HEART VALVES OCCURS WHEN THE VALVE DOES NOT CLOSE PROPERLY IN SYSTOLIC PHASE, WHICH RESULTS IN RETROGRADE FLOW OF BLOOD IN THE LEFT ATRIUM. THE TYPE AND CAUSE OF REGURGITATION VARIES DEPENDING UPON MULTIPLE FACTORS. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. HOWEVER, ADVANCES IN VALVE DESIGN AND BIOPROSTHETIC MATERIAL HAVE BEEN MADE WITH THE INTENTION OF REDUCING REGURGITATION BY PROVIDING MORE EFFICIENT HEMODYNAMICS AND LONGER TISSUE DURABILITY. WITHOUT ADDITIONAL INFORMATION OR RETURN OF THE DEVICE, THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. SEE ALSO REPORT 2015691-2014-01079 FOR THIS PATIENT. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS 31MM PORCINE MITRAL VALVE, IMPLANTED THREE (3) YEARS TWO (2) MONTHS, WAS EXPLANTED DUE TO PROSTHETIC VALVE DYSFUNCTION AND SEVERE MITRAL REGURGITATION. THE DEVICE WAS REPLACED WITH A 29MM PERICARDIAL VALVE AND PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385206 SEE H10. REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R