BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 8388671 · Received March 4, 2019

    Report

    Report Number
    2015691-2019-00721
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    February 1, 2011
    Report Date
    February 7, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2500P; BRAND NAME: EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS; PMA #P000007. STENOSIS AND/OR 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. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE ARTICLE "THE HOSPITAL RESULTS AND 1-YEAR OUTCOMES OF TRANSCATHETER AORTIC VALVE-IN-VALVE PROCEDURES AND TRANSCATHETER AORTIC VALVE IMPLANTATIONS IN THE NATIVE VALVES: THE RESULTS FROM THE SWISS-TAVI REGISTRY" BY AUTHOR ENRICO FERRARI ET AL., THE FOLLOWING VALVE-IN-VALVE EVENTS WERE IDENTIFIED AS PERTAINING TO THE FOLLOWING EDWARDS SURGICAL VALVES. BETWEEN FEBRUARY 2011 AND DECEMBER 2016, 157 CONSECUTIVE PATIENTS UNDERWENT TAVI VALVE-IN-VALVE PROCEDURES IN DEGENERATED BIOPROSTHETIC VALVES LEADING TO STENOSIS AND/OR REGURGITATION. VALVE-IN-VALVE PATIENTS WERE 78 +/- 9.1 YEARS OF AGE. THE IMPLANT DURATIONS WERE 9.2 +/- 4.6 YEARS. TWO PATIENTS WERE NOTED TO HAVE EDWARDS PRIMA PLUS VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178621 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R