BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 828941 · Received March 12, 2007

    Report

    Report Number
    2031527-2007-00008
    Event Type
    Other
    Date Received
    March 12, 2007
    Date of Event
    February 16, 2007
    Report Date
    March 12, 2007
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. CONCLUSION - OPERATIONAL CONTEXT CONTRIBUTED TO THE EVENT. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    PATIENT IMPLANT OF A BIFURCATED DEVICE AND TWO PROXIMAL CUFFS AT A CASE IN 2006 (PHYSICIAN'S 1ST CASE). IT WAS NOTED THAT THE PROXIMAL CUFF WAS PLACED ABOUT 10MM TOO LOW. HOWEVER, NO ENDOLEAK WAS NOTICED. AT 30-DAYS POST IMPLANT, THE PHYSICIAN NOTED THAT THERE MIGHT BE A SLIGHT TYPE I AND DECIDED TO MONITOR IT . PATIENT HAD A FOLLOW UP ANGIOGRAM WHERE THE PHYSICIAN NOTED A LARGE TYPE I ENDOLEAK. A SECONDARY PROCEDURE TO RESOLVE THE ENDOLEAK WITH ANOTHER PROXIMAL CUFF WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM STRAIGHT INFRARENAL CUFF STENT GRAFT MIH ENDOLOGIX, INC. 25-25-75L W06-0229

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention