BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT PROSTAR XL

    MDR report key: 1887379 · Received October 25, 2010

    Report

    Report Number
    MW5017937
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABBOTT VASCULAR DEVICE -PROSTAR XL- USED FOR ENDOVASCULAR REPAIR OF 5.5 CM AAA ON (B)(6) 2010. NO BLEEDING NOTED AT RIGHT FEMORAL INSERTION SITE AFTER USE. PATIENT INITIALLY STABLE BUT DEVELOPED MASSIVE INTRA ABDOMINAL HEMORRHAGE, REQUIRING EMERGENT RETURN TO OPERATING ROOM THAT REVEALED ONE OF THE SUTURES HAD NOT FULLY DEPLOYED AND WAS IN THE SUBCUTANEOUS FAT. MASSIVE RESUSCITATION NEEDED AND PATIENT GRADUALLY STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL DEVICE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| S