BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMMETRY BYPASS DEVICE

    MDR report key: 548700 · Received July 14, 2004

    Report

    Report Number
    MW1032689
    Event Type
    Other
    Date Received
    July 14, 2004
    Date of Event
    June 11, 2003
    Report Date
    June 25, 2004
    Manufacturer
    *
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    FOURTEEN MONTHS AFTER THE SYMMETRY BYPASS CONNECTOR (SBC) WAS IMPLANTED, CARDIAC CATHETERIZATION REVEALED 100% RE-OCCLUSION OF THE 2ND MARGINAL BRANCH. THE SBC WAS USED AT THIS LOCATION WITH A SAPHENOUS VEIN GRAFT. IT IS WORTHY TO NOTE THAT A SBC WAS ALSO USED WITH A SVG AT THE 1ST DIAGONAL BRANCH WITH NO RE-OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY BYPASS DEVICE GRAFT DEVICE FZP * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other