BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA MAIN BODY GRAFT

    MDR report key: 702899 · Received October 6, 2005

    Report

    Report Number
    1820334-2005-00271
    Event Type
    Other
    Date Received
    October 6, 2005
    Date of Event
    August 22, 2005
    Report Date
    September 6, 2005
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PROCEDURE WAS BEING PERFORMED FOR REPAIR OF ABDOMINAL AORTIC ANEURYSM. INFORMATION PROVIDED STATES THE STENT WAS PRIMED IN THE USUAL FASHION AND INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. IT WAS INSERTED OVER A LUNDEQUIST WIRE GUIDE INTO THE PATIENT. THE PHYSICIAN DESCRIBED THE STENT AS UNUSUALLY STIFF ON INSERTION. THE ATTEMPT TO UN-SHEATH THE BODY STENTS WAS UNSUCCESSFUL AS IT WAS TOO STIFF TO DEPLOY. THE ENTIRE DEVICE WAS REMOVED FOR INSPECTION, WHICH REVEALED THE SHEATH HAD ONLY PARTIALLY DEPLOYED, COVERING THE FIRST 5MM OF THE STENT. IT WAS ALSO NOTED THE SUPRARENAL SAFETY WIRE WAS EXPOSED. AT THIS TIME, A DECISION WAS MADE TO STOP THE PROCEDURE AS THE PHYSICIAN WAS UNSURE THE SAFETY WIRE WOULD APPEAR AS IT WAS REVEALED AT THIS POINT. THE PATIENT WAS RETURNED TO HIS ROOM AND WILL UNDERGO FURTHER SURGERY TO BOTH GROINS AT A LATER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY GRAFT ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA F1676032

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other