BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 12763179 · Received November 7, 2021

    Report

    Report Number
    2015691-2021-06195
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 9, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: B4, G3, G6, H2, H6 THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT'S UNDERLYING PATHOLOGIES. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    BIOPROSTHETIC TISSUE VALVES CAN DETERIORATE WITH TIME AND EVENTUALLY FAIL CONTRIBUTING TO REGURGITATION AND/OR STENOSIS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS 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. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR REGURGITATION AND/OR STENOSIS. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    EDWARDS LIFESCIENCES LLC., RECEIVED NOTIFICATION THAT A PATIENT WITH A PERIMOUNT VALVE IMPLANTED IN AN UNKNOWN POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION FOR UNKNOWN REASON. A NON-EW VALVE WAS IMPLANTED. ALL INFORMATION PERTINENT TO THIS CASE WAS RECEIVED AND DOCUMENTED IN THE FILE, AS PER LAST FOLLOW-UP DONE WITH THE SALES REP. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658598 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| L