BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1516322 · Received October 23, 2009

    Report

    Report Number
    2031527-2009-00140
    Event Type
    Injury
    Date Received
    October 23, 2009
    Date of Event
    September 16, 2009
    Report Date
    October 22, 2009
    Manufacturer
    ENDOLOGIX, INC. - IRVINE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 34-34-80L, LOT NO. W08-1567R-021, EXPIRATION DATE: 08/01/11. MODEL NO. 34-34-100RL, LOT NO. W08-2284-001, EXPIRATION DATE: 11/01/11. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PATIENT PRESENTED WITH CHALLENGING ANATOMY; UNKNOWN IF PATIENT MET CRITERIA FOR INDICATIONS FOR USE. OPERATIONAL CONTEXT CONTRIBUTED TO EVENT

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH CHALLENGING NECK ANATOMY; IN 2009, HAD SUCCESSFUL IMPLANT OF A 28-16-140BL BIFURCATED DEVICE, ONE 34-34-80L PROXIMAL EXTENSION, ONE 34-34-100RL PROXIMAL EXTENSION AND A 20-25-65T LIMB EXTENSION. FOLLOW UP REVEALED A PROXIMAL AND DISTAL TYPE I ENDOLEAK. EIGHT MONTHS LATER, THE PATIENT WAS TREATED WITH AN ADDITIONAL 34-34-80L PROXIMAL EXTENSION AND 20-20-55L LIMB EXTENSION WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. - IRVINE 28-16-140BL W08-1198-014

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention