BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1041150 · Received May 12, 2008

    Report

    Report Number
    1820334-2008-00258
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: EACH ZENITH DEVICE IS SHIPPED WITH AN "INSTRUCTIONS FOR USE" (IFU) BOOKLET THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO ADVISES ON APPROPRIATE FOLLOW-UP, SO THAT LEAKS SHOULD THEY OCCUR CAN BE IDENTIFIED AND ADDRESSED BEFORE CAUSING CLINICAL PROBLEMS. THE DEVICE REMAINS IMPLANTED AND NO FILMS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT A DISTAL TYPE I ENDOLEAK OCCURRED DUE TO ANATOMICAL CHANGES OVER TIME AND PT ANATOMY.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2008. ONE MAIN BODY GRAFT AND TWO ILIAC LEG GRAFTS WERE PLACED. AT A FOLLOW-UP CT IN 2007, THERE WAS NO LEAK. THE PT PRESENTED EMERGENTLY WITH BACK PAIN AND LOW BLOOD PRESSURE. A CT AT THAT TIME INDICATED A RUPTURING AAA. IN 2008, THE INTRAOPERATIVE ANGIOGRAM NOTED THAT THE PT HAD A LEFT ILIAC DISTAL RETROGRADE LEAK FILLING THE ANEURYSM. THE PHYSICIAN ADDED AN ILIAC LEG GRAFT TO EXTEND TO THE HYPO AND ACHIEVED A SEAL. THE LEAK WAS COMPLETELY RESOLVED ON THE FINAL RUN. THE PT IS DOING WELL OTHER THAN HIS COPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1731865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention