BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 486235 · Received September 22, 2003

    Report

    Report Number
    1820334-2003-00143
    Event Type
    Injury
    Date Received
    September 22, 2003
    Date of Event
    August 26, 2003
    Report Date
    August 26, 2003
    Manufacturer
    COOK INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER STANDARD INSERTION OF THE MAIN BODY GRAFT, THE SUPRARENAL COMPONENT WAS DEPLOYED. NO ANGIOGRAM WAS PERFORMED PRIOR TO REMOVING THE CONTRALATERAL INTRODUCER SHEATH AND DEPLOYING THE ILIAC LEG. UPON COMPLETION OF THE GRAFT INSERTION, A POST DEPLOYMENT ANGIOGRAM WAS PERFORMED THAT DOCUMENTED OCCLUSION OF THE LEFT HYPOGASTRIC ARTERY. SINCE THE RIGHT HYPOGASTRIC WAS PATENT AND THERE DID NOT APPEAR TO BE ANY DISTAL ENDOLEAKS AT THE LEFT ILIAC LANDING ZONE, NO FURTHER INTERVENTION WAS ATTEMPTED. PT DISCHARGED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT MIH COOK INC NA 1244433

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention