BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINK SYSTEM

    MDR report key: 892115 · Received October 24, 2006

    Report

    Report Number
    2031527-2006-00040
    Event Type
    Malfunction
    Date Received
    October 24, 2006
    Date of Event
    October 17, 2006
    Report Date
    October 23, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE INDICATES THAT THE REPORT IS CONSISTENT WITH A PREVIOUS REPORT (MDR#2031527-2006-021), IN WHICH INCORRECT BONDING WAS DUE TO MANUFACTURING VARIABILITY. BOTH DEVICES WERE FROM THE SAME LOT, WHICH HAS BEEN COMPLETELY CONSUMED. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. THE INCORRECT BONDING OF ONE UNIT WAS NOTED IN THE LOT RECORDS, WHICH WAS ADDRESSED. CORRECTIVE ACTION WAS IMPLEMENTED. NO OTHER SIMILAR REPORTS HAVE BEEN RECEIVED.

    Description of Event or Problem · 1

    AFTER POSITIONING THE DEVICE OVER THE AORTIC BIFURCATION, THE PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING THE MAIN BODY OF THE STENT GRAFT. WHILE PUSHING ON THE PUSHER ROD, THE FRONT TIP SEPARATED FROM THE FRONT SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE DEVICE WITHOUT INCIDENT. A NEW DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W06-0556

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other