BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1130451 · Received August 19, 2008

    Report

    Report Number
    2031527-2008-00034
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE DEVICE MET SPECIFICATIONS PRIOR TO RELEASE. RELATED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    (PHYSICIAN'S SECOND ENDLOGIX CASE) PT PRESENTED WITH SEVERE NECK ANGULATION. DURING USE OF THE DUAL LUMEN CATHETER (NOTE: MAY HAVE BEEN OVER MANIPULATED/ROTATED), FLUOROSCOPY CONFIRMED THAT THE WIRES HAD NOT CROSSED. DURING INTRODUCTION OF THE BIFURCATED DELIVER SYSTEM, WHEN THE FRONT/OUTER SHEATHS REACHED THE AORTIC BIFURCATION, A WIRE WRAP HAD OCCURRED. THE WIRE WRAP WAS RESOLVED AFTER TWO ATTEMPTS OF ROTATIONS IN CLOCKWISE AND COUNTER CLOCKWISE POSITIONS. HOWEVER, WHEN THE LIMBS WERE SPLAYED OPEN, THE DEVICE "RECOILED/SPUN" AND THE WIRE WRAP WAS REINTRODUCED. IN AN ATTEMPT TO RESOLVE, THE DELIVERY SYSTEM WAS ROTATED, ADVANCED AND RETRACTED, HOWEVER, UNDER FLUORO, THERE WAS NO MOVEMENT IN THE DEVICE. THE DECISION WAS MADE TO DEPLOY THE DEVICE WHERE IT WAS. THE PHYSICIAN WAS UNABLE TO DEPLOY THE MAIN BODY, MOST LIKELY DUE TO POLYIMIDE DAMAGE FROM OVER TORQUING OF THE DELIVERY SYSTEM. THE PT WAS CONVERTED TO OPEN REPAIR. WHEN THE PT'S AORTA WAS EXPOSED, THE PHYSICIAN DECIDED TO CONTINUE WITH ENDOVASCULAR REPAIR WITH THE ENDOLOGIX DEVICE. THE EXPOSED AORTA WAS ONLY TO QUICKLY GAIN CONTROL IN THE CASE OF A PERFORATION. THE DELIVERY SYSTEM WAS RETRACTED, THE CONTRALATERAL LIMB WAS PROLAPSED, AND THE DEVICE WAS REMOVED. A NEW BIFURCATED DEVICE WAS OPENED AND DEPLOYED WITHOUT INCIDENT. A PROXIMAL CUFF WAS INTRODUCED AND ADVANCED QUICKLY. THE DELIVERY SYSTEM INADVERTENTLY PUSHED THE BIFURCATED DEVICE SUPERIORLY, WHICH PUSHED THE TWO ILIAC LIMBS OF THE BIFURCATED STENT GRAFT OUT OF THE COMMON ILIACS AND ABOVE THE AORTIC BIFURCATION. AN ATTEMPT WAS MADE TO BRING THE BIFURCATED DEVICE DOWN USING A CODA BALLOON, BUT, UNABLE TO GET THE LIMBS BACK INTO THE COMMON ILIACS. THE LIMBS WERE EXTENDED USING TWO LIMB EXTENSIONS. A PROXIMAL TYPE I ENDOLEAK WAS RESOLVED BY PLACING A PALMAZ STENT IN THE PROXIMAL PORTION OF THE CUFF. A CODA BALLOON WAS USED TO ENSURE GOOD PROXIMAL AND DISTAL SEAL WITH GOOD RESULTS. NO ENDOLEAKS WERE NOTED AT THE CLOSE OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL (SP) W08-0360R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention