BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1546013 · Received November 23, 2009

    Report

    Report Number
    2031527-2009-00171
    Event Type
    Injury
    Date Received
    November 23, 2009
    Date of Event
    October 23, 2009
    Report Date
    November 19, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFO: MODEL# 25-25-75L, LOT# W09-1444-013, EXP DATE: 06/2009. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. ENDOLEAK IS A KNOWN RISK OF THE PROCEDURE. PT'S ANATOMY REMODELED POST-PROCEDURE RESULTING IN ENDOLEAK.

    Description of Event or Problem · 1

    IN 2009, PT PRESENTED WITH NECK MEASURING APPROXIMATELY 15MM, >90 DEGREES ANGULATION, AND TIGHT ILIACS (LUMEN LESS THAN 7MM); HAD IMPLANT OF A 25-16-140BL BIFURCATED DEVICE AND TWO PROXIMAL EXTENSIONS. THE PROXIMAL END OF THE 2ND EXTENSION LANDED IN THE ANGULATION; COULD NOT GET GOOD APPOSITION. ANOTHER PROXIMAL EXTENSION WAS PLACED, ALONG WITH A PALMAZ STENT WITH GOOD PROXIMAL SEAL. THE PHYSICIAN ALSO EXTENDED DOWN BILATERALLY AND PLACED ONE LIMB EXTENSION ON EACH SIDE WITH GOOD RESULTS. A 30-DAY F/U STILL SHOWED GREAT SEAL, AND THE ANATOMY APPEARED TO BE STRAIGHTENED. AT THE NEXT F/U, CT REVEALED A DISTAL TYPE I ENDOLEAK ON THE RIGHT SIDE. THE PHYSICIAN FELT THAT IT MAY HAVE BEEN DUE TO REMODELING OF THE ANATOMY. FOUR MONTHS LATER, THE PT WAS TREATED WITH AN ADDITIONAL LIMB EXTENSION, AND WITH BALLOON DILATATION, OBTAINED GOOD SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 25-25-75L W09-1444-012

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention