BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE VASCULAR GRAFT

    MDR report key: 89085 · Received May 5, 1997

    Report

    Report Number
    2242352-1997-00041
    Event Type
    Injury
    Date Received
    May 5, 1997
    Date of Event
    March 3, 1997
    Report Date
    April 8, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GRAFT IMPLANTED IN APRIL 1996 FOR AN ABOVE-KNEE FEMORO-POPLITEAL BYPASS. NO NOVEMBER 1996, THE GRAFT THROMBOSED AND WAS SUCCESSFULLY THROMBECTOMIZED. ON MARCH 3, 1997, THE GRAFT WAS EXPLANTED DUE TO AN ANASTOMOTIC PSEUDOANEURYSM AND A THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTAGE VASCULAR GRAFT Implant SEALED VASCULAR GRAFT DSY MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 375408 274271

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other