BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2708777 · Received March 23, 2012

    Report

    Report Number
    2031527-2012-00043
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 IMPLANT OF A 34MM AORTIC EXTENSION IT WAS NOTED ON THE ANGIOGRAPHIC IMAGE THAT THE RADIOPAQUE TIP WAS NOT RETRACTING WITH THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED FROM THE PT IT WAS NOTED THE POLYIMIDE TUBING BECAME DETACHED FROM THE PUSHER ROD; LEAVING THE TIP INSIDE THE PT. THE PHYSICIAN WAS ABLE TO REMOVE THE RADIOPAQUE TIP USING A SNARE. 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. 34-34-120RLE W10-4139-003

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR