BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAMSHIELD VANTAGE WOVEN SINGLE VELOUR VASCULAR GRAFT

    MDR report key: 2113019 · Received May 27, 2011

    Report

    Report Number
    MW5020791
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEADOX MEDICALS
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT NOTED SWELLING IN LOWER ABDOMINAL AREA 3-4 WEEKS PRIOR TO EXAMINATION. WIFE STATES AREA HAS GOTTEN BIGGER, NO HISTORY INJURY. HAD PLACEMENT OF FEM-FEM ARTERY BYPASS GRAFT IN 1999 DUE TO PERIPHERAL VASCULAR DISEASE AND LEFT LOWER EXTREMITY ISCHEMIA. AREA OF RUPTURE WAS TRAVERSED WITH A GLIDEWIRE AND A GLIDE CATHETER AND THEN SUCCESSFULLY DEPLOYED A 9X15 VIABAHN GRAFT TO RELINE WHAT APPEAR TO BE A DETERIORATING FEM-FEM GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAMSHIELD VANTAGE WOVEN SINGLE VELOUR VASCULAR GRAFT VASCULAR GRAFT DSY MEADOX MEDICALS 1554096

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening