BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2708795 · Received March 23, 2012

    Report

    Report Number
    2031527-2012-00045
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS. NO ISSUES WERE NOTED. EVALUATION OF THE RETURNED DEVICE CONFIRMED THE SEPARATION POLYIMIDE TUBE AND THE PEBAX INNER CORE DUE TO A UV ADHESIVE BOND FAILURE.

    Description of Event or Problem · 1

    AFTER SUCCESSFUL DEPLOYMENT OF A 34MM AORTIC EXTENSION THE PHYSICIAN UNDOCKED THE EXPRESS DELIVERY SYSTEM FROM THE INTRODUCER SHEATH HEMOSTASIS HANDLE. WHEN THE PHYSICIAN WAS REMOVING THE EXPRESS DELIVERY SYSTEM FROM THE GUIDEWIRE IT WAS NOTED THE TIP BECAME DETACHED FROM THE INNER CORE AND REMAINED ON THE GUIDEWIRE. THE PHYSICIAN REMOVED THE DETACHED TIP FROM THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE DELIVERY SYSTEM IS BEING RETURNED FOR EVALUATION. THERE IS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-100RLE W11-0836-003

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR