BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 8117684 · Received November 29, 2018

    Report

    Report Number
    2015691-2018-04950
    Event Type
    Injury
    Date Received
    November 29, 2018
    Date of Event
    December 1, 2009
    Report Date
    November 5, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    REGURGITATION, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS/REPLACEMENTS 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 REPORTED EVENT CANNOT BE CONFIRMED SINCE THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. HOWEVER, THIS EVENT WAS MOST LIKELY IMPACTED BY THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH SVD. THERE WAS NO INDICATION OR ALLEGATION OF A DEVICE MALFUNCTION CONTRIBUTING TO THE EVENT. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #6625-LP; BRAND NAME: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS; PMA #P870077.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE ARTICLE, "TRANSCATHETER MITRAL VALVE-IN-VALVE IMPLANTATION IN PATIENTS WITH DEGENERATED BIOPROSTHESES" BY AUTHORS MORITZ SEIFFERT ET AL, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: (B)(6) YEAR-OLD PATIENT WITH A SAV PORCINE VALVE, IMPLANTED IN THE MITRAL POSITION FOR APPROXIMATELY 16 YEARS, UNDERWENT A VALVE-IN-VALVE REPLACEMENT DUE TO DEGENERATION WITH REDUCED LEAFLET MOBILITY CAUSING MITRAL REGURGITATION. A 23MM SAPIEN VALVE WAS IMPLANTED WITHIN THE SURGICAL VALVE USING A TRANSAPICAL APPROACH. IMPLANTATION WAS SUCCESSFUL. APICAL BLEEDING OCCURRED ON POD #4 WITH AN UNEVENTFUL RECOVERY. AT THE 6-MONTH FOLLOW-UP VISIT, THE PATIENT WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957821 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R