BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1727240 · Received June 17, 2010

    Report

    Report Number
    2031527-2010-00075
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 16, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-75RL LOT NO. W10-0788-003 EXPIRATION DATE. 4/21/2013. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. USE OF DEVICE WITH 12MM AORTIC NECK LENGTH IS OFF-LABEL PER INDICATIONS FOR USE. THE PROXIMAL EXTENSION WAS INADVERTENTLY PUSHED UP ABOVE THE RENALS DURING THE PROCEDURE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AORTIC NECK 12MM LENGTH (OFF-LABEL). ACCESS AND DEPLOYMENT OF A 25-16-120BL BIFURCATED DEVICE AND A 28-28-75L PROXIMAL EXTENSION WERE UNEVENTFUL. THE 28-28-75L MOVED DOWN SLIGHTLY, SO ANOTHER 28-28-75L PROXIMAL EXTENSION WAS PLACED. A PROXIMAL ENDOLEAK WAS NOTED. A 28-28-75RL SUPRARENAL EXTENSION WAS PLACED JUST BELOW THE LOWEST RENAL. A SLIGHT ENDOLEAK WAS STILL NOTED. THE PHYSICIAN WANTED TO USE A P4010 PALMAZ STENT HOWEVER DURING DILATOR/INTRODUCER SHEATH READVANCEMENT, THE DILATOR INADVERTENTLY PUSHED THE CUFF PROXIMAL CAUSING IT TO COVER THE RENALS. THE PHYSICIAN ATTEMPTED TO SNARE BUT WAS UNSUCCESSFUL. THE PATIENT WAS CONVERTED TO OPEN REPAIR AND IS REPORTED TO HAVE TOLERATED THE PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-120BL W10-1042-007

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention