BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1546012 · Received November 23, 2009

    Report

    Report Number
    2031527-2009-00172
    Event Type
    Injury
    Date Received
    November 23, 2009
    Date of Event
    October 22, 2009
    Report Date
    November 19, 2009
    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

    ADDITIONAL DEVICE INFO: MODEL# 34-34-80L, LOT# W09-2437-012, EXP DATE: 09/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. ENDOLEAK IS A KNOWN RISK OF THE PROCEDURE. IT IS UNK IF THE PT ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PT PRESENTED WITH A REVERSE TAPER NECK, MEASURING 23MM-32MM OVER AN 18MM LENGTH, WITH ANTERIOR ANGULATION. ACCESS AND DEPLOYMENT WITH A 28-16-120BL BIFURCATED DEVICE AND A 34-34-100RLE SUPRARENAL PROXIMAL EXTENSION WERE UNEVENTFUL, HOWEVER, AFTER POST-DILATATION WITH A BALLOON, A LARGE PROXIMAL TYPE I ENDOLEAK WAS NOTED. A 34-34-80L INFRARENAL PROXIMAL EXTENSION WAS DEPLOYED, AND AFTER TWO BALLOON POST-DILATATION ATTEMPTS, THE ENDOLEAK PERSISTED. THE PHYSICIAN DECIDED TO END THE PROCEDURE AND MONITOR THE PT AT 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 34-34-100RLE W09-2440-004

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention