BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMMETRY BYPASS CONNECTOR

    MDR report key: 548743 · Received July 14, 2004

    Report

    Report Number
    MW1032695
    Event Type
    Other
    Date Received
    July 14, 2004
    Date of Event
    August 6, 2003
    Report Date
    June 8, 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

    TWELVE MONTHS AFTER THE SYMMETRY BYPASS CONNECTOR (SBC) WAS IMPLANTED, CARDIAC CATHETERIZATION REVEALED 100% RE-OCCLUSION OF THE 2ND MARGINAL AND THE 1ST DIAGONAL BRANCHES. THE SBC WAS USED IN THE 2ND MARGINAL BRANCH WITH A SAPHENOUS VEIN GRAFT (SVG); HOWEVER, A DIFFERENT DEVICE WAS USED AT THE 1ST DIAGONAL BRANCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other