BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1033326 · Received April 23, 2008

    Report

    Report Number
    1820334-2008-00209
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 24, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: COOK'S INSTRUCTIONS FOR USE DOES INDICATE TO READ ALL INSTRUCTIONS CAREFULLY. FAILURE TO PROPERLY FOLLOW THE INSTRUCTIONS, WARNINGS, AND PRECAUTIONS, MAY LED TO SERIOUS SURGICAL CONSEQUENCES OR INJURY TO THE PT. INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATION. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT THE EVENT WAS CAUSED BY INCORRECT PLACEMENT OF GRAFT DUE TO USER ERROR.

    Description of Event or Problem · 1

    A MALE WITH ANGULATED ILIACS UNDERWENT AAA REPAIR AS LABELED IN 2008. WHEN REMOVING THE LEFT ILIAC LEG GRAFT FROM THE PACKAGE, THE PT'S OPERATING TABLE WAS MOVED INADVERTENTLY. ACCORDINGLY, THE INTERNAL ILIAC ARTERY WAS COVERED WITH THE LEFT ILIAC LEG GRAFT AND WAS VERIFIED BY ANGIOGRAPHY. AFTER THE CONTRALATERAL ILIAC LEG GRAFT WAS PLACED, THE MAIN BODY DELIVERY SYSTEM WAS PULLED DOWN MORE THAN BEFORE. THE ILIAC LEG DELIVERY SYSTEM COULD NOT PUSH UP TO THE LANDING ZONE AND COVERED THE INTERNAL ILIAC ARTERY. FINALLY, THE PHYSICIAN PLACED THE RIGHT ILIAC LEG GRAFT INTO THE EXTERNAL ILIAC ARTERY WITHOUT OVERWRAP. HE THEN PLACED AN ADDITIONAL LEG GRAFT AS A BRIDGE. THE NEXT DAY, THE PHYSICIAN NOTED THAT ABDOMINAL PAIN AND BLOOD-FLOW WAS NOT A PROBLEM AT THIS TIME. (SEE ALSO 1820334-2008-00210).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA F2136234

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention