BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1178116 · Received September 22, 2008

    Report

    Report Number
    2031527-2008-00053
    Event Type
    Other
    Date Received
    September 22, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE DEVICE MET SPECIFICATIONS PRIOR TO RELEASE. PATIENT'S LARGE LUMBAR VESSEL AND OPERATIONAL CONTEXT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    PATIENT HAD SUCCESSFUL IMPLANT OF A BIFURCATED DEVICE, A PROXIMAL CUFF, AND A LIMB EXTENSION IN 2006, GOOD SEAL AT END OF PROCEDURE. DURING SEVERAL FOLLOW UP VISITS (INCLUDING THE MOST RECENT IN 2008), CT REVEALED A PERSISTENT ENDOLEAK, HOWEVER, UNABLE TO DETERMINE WHETHER A DISTAL TYPE I ENDOLEAK OR A TYPE II. THE FOLLOWING MONTH, THE PATIENT WAS BROUGHT IN TO TREAT THE ENDOLEAK WITH A LIMB EXTENSION. FINAL ANGIO SHOWED A PERSISTENT TYPE II ENDOLEAK STEMMING OFF OF A LARGE LUMBAR VESSEL. PT WILL MOST LIKELY BE SCHEDULED FOR A COIL EMBOLIZATION OF THE LUMBAR VESSEL AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W08-0867

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention