BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1667806 · Received April 27, 2010

    Report

    Report Number
    2031527-2010-00043
    Event Type
    Injury
    Date Received
    April 27, 2010
    Date of Event
    March 26, 2010
    Report Date
    April 26, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NO. 25-25-75L LOT NO. W10-0341-022 EXPIRATION DATE: 03/09/2013;MODEL NO. 25-25-95RL LOT NO. W09-1591-017 EXPIRATION DATE: 06/19/2012.REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. (B) (4) PATIENT HAD TWO 90 DEGREE ANGLES IN THE AORTIC NECK; ANATOMY IS OFF-LABEL PER INDICATIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT ANATOMY REPORTED WITH TWO 90° ANGLES IN THE AORTIC NECK (OFF-LABEL). THE PHYSICIAN HAD DIFFICULTY ADVANCING A TECH DEVICE STIFF WIRE INTO THE NECK DUE TO THE SEVERE ANGULATION. THE STIFF WIRE WAS TRADED OUT FOR A LUNDERQUIST. BALLOONING BILATERALLY WAS REQUIRED DUE TO NARROW, TORTUOUS ILIACS. THE 25-16-140BL BIFURCATED STENT GRAFT WAS DEPLOYED AND PLACED AT THE BIFURCATION. TWO 25-25-75L PROXIMAL EXTENSIONS WERE PLACED WITH GOOD OVERLAP OF THE BIFURCATED STENT GRAFT, BUT DURING PLACEMENT IN THE SEVERELY ANGULATED AORTA, COULD NOT GET SEAL BECAUSE THE FIRST EXTENSION SLIPPED WITHIN THE MAIN BODY OF THE BIFURCATED AND MOST PROXIMAL EXTENSION SLIPPED DOWN INTO THE DISTAL CUFF. THE PHYSICIAN WAS ABLE TO WEDGE THE MOST PROXIMAL EXTENSION INTO PLACE USING THE TIP OF THE DELIVERY SYSTEM. A 25-25-95RL SUPRARENAL PROXIMAL EXTENSION [W09-1591-017] WAS ADVANCED, BUT WHEN ATTEMPTING TO DEPLOY, IT SLIPPED DISTALLY ALSO DUE TO THE SEVERE ANGULATION. THIS EXTENSION WAS ALSO WEDGED INTO PLACE AS DESCRIBED PREVIOUSLY. A PALMAZ STENT WAS PLACED TO ATTEMPT TO SUPPORT THE SUPRARENAL EXTENSION AT THE RENALS. THE PHYSICIAN TRIED TO OBTAIN GUIDEWIRE ACCESS VIA A BRACHIAL APPROACH TO PLACE A THIRD EXTENSION, BUT WAS NOT ABLE TO ACCESS TO PLACE A WIRE. A 25-25-55L [W09-2904-015] WAS USED TO ATTEMPT TO BRIDGE THE GAP BETWEEN THE 25X75L AND 25X95RL EXTENSIONS. AFTER PLACING THE 4TH EXTENSION, THE SUPRARENAL EXTENSION SLIPPED DISTALLY BUT THE PALMAZ MAINTAINED ITS POSITION. AN ADDITIONAL 25-25-75L EXTENSION WAS ATTEMPTED TO BE PLACED JUST BELOW THE LEFT RENAL, COVERING THE RIGHT (LOWEST) RENAL BUT DUE TO THE SEVERE TORTUOSITY AND ANGULATION OF THE NECK WAS UNABLE TO GAIN APPOSITION. AT THAT TIME THE PHYSICIAN DECIDED TO CONVERT THE PATIENT TO OPEN REPAIR, REMOVING ALL EXTENSIONS AND LEAVING THE BIFURCATED STENT GRAFT IN PLACE. THE PATIENT WAS REPORTED TO HAVE BEEN DISCHARGED FROM THE HOSPITAL SINCE THE PROCEDURE AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 25-25-75L W09-3308-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention