BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1132083 · Received August 20, 2008

    Report

    Report Number
    2031527-2008-00047
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    June 26, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 8/5/08, PT PRESENTED WITH TORTUOUS ILIACS AND A 5CM ANEURYSM IN RIGHT ILIAC; TREATED WITH A BIFURCATED DEVICE, TWO PROXIMAL CUFFS, AND A LIMB EXTENSION ON ONE MONTH EARLIER. WHEN PULLING/REMOVING THE CONTRALATERAL LIMB SHEATH AND WIRE, THE PHYSICIAN INADVERTENTLY REMOVED THE .014 WIRE. DUE TO THE TORTUOSITY OF THE ILIAC VESSELS, ATTEMPTS TO RE-ADVANCE THE .014 WIRE WITH A GOOSENECK SNARE WAS UNSUCCESSFUL, THERE WERE NO END SNARES AVAILABLE. DURING THIS PROCESS, THE PT LOST SOME BLOOD AND THE PROCEDURE TIME WAS ABOUT 4-5 HOURS. THE PHYSICIAN WANTED TO BRING BACK AFTER OBTAINING SOME END SNARES IN ORDER TO COMPLETE THE PROCEDURE. THE PT WAS BROUGHT BACK ON TWO DAYS LATER ON EVENT DATE, TO PLACE THE LAST LIMB EXTENSION. OUTCOME WAS GOOD AND THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W08-1045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention