BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 787087 · Received July 12, 2006

    Report

    Report Number
    2031527-2006-00020
    Event Type
    Other
    Date Received
    July 12, 2006
    Date of Event
    May 12, 2006
    Report Date
    July 12, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED ON A 30-DAY FOLLOW UP FORM (DATED 6/27/06) FOR A PATIENT IMPLANT IN 2006, THAT IN A FOLLOW UP VISIT IN 3/06; THE PATIENT HAD A FOLLOW UP CT - FOUND NO ENDOLEAK, BUT STENOSIS OF RIGHT LIMB. TWELVE DAYS LATER, THE PATIENT RETURNED WITH SYMPTOMS OF CLAUDICATION IN THE RIGHT LOWER LIMB. THE PATIENT WAS TREATED APPROX ONE MONTH LATER WITH BALLOONING AND A STENT WAS PLACEDD IN THE RIGHT ILIAC LIMB OF THE EXISTING STENT GRAFT. TWO WEEKS LATER, THE PATIENT RETURNED FOR A FOLLOW UP VISIT AND HAD NO SYMPTOMS OF CLAUDICATION AND STRONG PERIPHERAL PULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED DEVICE MIH ENDOLOGIX, INC. 28-16-139BL W05-1023

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention POWERLINK INFRARENAL CUFF(28-28-75L, W05-1047).| POWERLINK LIMB EXTENSION(16-16-88L, W05-0997).