BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA MAIN BODY DELIVERY SYSTEM

    MDR report key: 1062733 · Received June 17, 2008

    Report

    Report Number
    1820334-2008-00314
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 18, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A FEMALE UNDERWENT INITIAL AAA REPAIR IN 2007. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. FOLLOW-UP CT WAS UNDETERMINED, SO THE PHYSICIAN WENT INTO A SECOND PROCEDURE TO VERIFY WHAT SHE THOUGHT WAS A TYPE II ENDOLEAK. HOWEVER, IT APPEARED THIS WAS A TYPE 1 ENDOLEAK. THIS PT HAD AN ACCESSORY RENAL ARTERY WHICH THE PHYSICIAN TRIED TO SAVE AND THERE IS A LITTLE CALCIUM THERE AS WELL. THE PHYSICIAN PLACED A MAIN BODY EXTENSION GRAFT DURING THE SECOND PROCEDURE, WHICH WAS IN 2008. THIS REPAIRED THE ENDOLEAK. ONE WEEK AFTER THE CUFF PLACEMENT, THE PT HAD A PE. THE PHYSICIAN SAID THIS HAD NOTHING TO DO WITH THE PROCEDURE OR THE DEVICE. THE PHYSICIAN FELT THE PT MIGHT HAVE HAD AN UNDERLYING ISSUE PRIOR TO ZENITH PLACEMENT THAT WENT UNDETECTED. AS AT 5 DAYS POST PROCEDURE, ON FOLLOW-UP IT APPEARED THAT THE CUFF HAD MOVED AND THE LEAK WAS BACK. AT THIS TIME, ADDITIONAL SURGERY HAS NOT BEEN SCHEDULED (SEE ALSO 1820334-2008-00315). PT DEVELOPED A LEAK AFTER THE SECOND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA MAIN BODY DELIVERY SYSTEM MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1921082

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention