BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 826686 · Received March 1, 2007

    Report

    Report Number
    MW1042075
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    October 25, 2006
    Report Date
    November 7, 2006
    Manufacturer
    *
    Product Code
    FGE
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FROM PTCA LEFT EXTERNAL ILIAC ARTERY. INABILITY TO DELIVER THE STENT AND DISSECTION IN THE LEFT COMMON AND EXTERNAL ILIAC ARTERIES. PATIENT TO SURGERY FOR EMERGENT AORTO BIEXTERNAL ILIAC BYPASS AND RETRIEVAL OF STENT AND BALLOON FROM DISTAL ABDOMINAL AORTA AT THE ORIGINS OF THE COMMON ILIAC ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR BILIARY STENT - WAVEMAX FGE * H3761 45550109 (22) 80105093395639

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention