BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2132866 · Received June 17, 2011

    Report

    Report Number
    2031527-2011-00034
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    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

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE EXPLANTED STENT GRAFT AND THE FRONT TIP WERE RETURNED TO ENDOLOGIX FOR EVALUATION. THE FRONT TIP WAS RETURNED SEPARATED FROM THE INNER CORE OF THE BIFURCATED DELIVERY SYSTEM. THE INTERIOR THREADS OF THE FRONT TIP WERE EXAMINED UNDER MICROSCOPE FOR EVIDENCE OF ADHESIVE. IT APPEARED THAT THERE WAS ADHESIVE PRESENT ON THE INTERIOR THREADS OF THE FRONT TIP. THE SEPARATION OF THE FRONT TIP APPEARS TO BE DUE TO THE MULTIPLE ROTATIONS MADE BY THE PHYSICIAN IN AN ATTEMPT TO DISLODGE THE FRONT TIP FROM THE LIMB OF THE BIFURCATED STENT GRAFT. THE IFU WARNS THAT EXCESSIVE FORCE USED TO ADVANCE OR WITHDRAW THE CATHETER WHEN RESISTANCE IS ENCOUNTERED MAY RESULT IN VESSEL OR CATHETER DAMAGE.

    Description of Event or Problem · 1

    AFTER SUCCESSFUL DEPLOYMENT OF A 25-16-100BL BIFURCATED DEVICE, THE PHYSICIAN WAS UNABLE TO RETRACT THE INNER CORE. THE PHYSICIAN ROTATED THE INNER CORE SEVERAL TIMES IN EACH DIRECTION TO ATTEMPT TO RETRACT THE INNER CORE. THE INNER CORE THEN WAS RETRACTED AND REMOVED FROM THE INTRODUCER SHEATH, AT WHICH POINT IT WAS NOTED THE RADIOPAQUE TIP HAD UNSCREWED FROM THE INNER CORE AND WAS STILL INSIDE THE PATIENT. THE PHYSICIAN CONVERTED TO AN OPEN REPAIR TO RETRIEVE THE RADIOPAQUE TIP. THE PATIENT WAS REPORTED TO TOLERATE THE PROCEDURE WELL. THE BIFURCATED STENT GRAFT AND THE RADIOPAQUE TIP WERE RETAINED BY THE SALES REPRESENTATIVE AND WILL BE RETURNED FOR EVALUATION; HOWEVER, THE DELIVERY SYSTEM AND INNER CORE WERE DISPOSED OF BY THE USER FACILITY AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-100BL W10-2378-010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention