BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1877235 · Received October 20, 2010

    Report

    Report Number
    2031527-2010-00121
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ENDOLOGIX, INC
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES: INFRARENAL BIFURCATED STENT GRAFT. MODEL# 28-16-120, LOT# W10-0122-008, EXPIRATION DATE: 02/01/2013. THE STENT GRAFTS WERE RETURNED TO ENDOLOGIX AND EVALUATED. THERE WAS NO INDICATION OF ANY DAMAGE TO EITHER GRAFT. THERE IS NO INDICATION THAT THE EVENT WAS DUE TO A DESIGN OR MANUFACTURING ISSUE. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. (B)(4) USE OF DEVICE WITH AORTIC NECK LENGTH OF 10MM IS OFF-LABEL PER THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PROXIMAL NECK LENGTH OF 10MM (OFF LABEL). PHYSICIAN WAS AWARE PRIOR TO THE CASE THAT SEAL WITH THE DEVICE MAY NOT BE POSSIBLE DUE TO THE PATIENT¿S ANATOMY, WHICH COULD RESULT IN AN OPEN REPAIR. A 28-16-120BL BIFURCATED DEVICE AND A 34-34-80LE AORTIC EXTENSION WERE IMPLANTED. A PROXIMAL TYPE I ENDOLEAK WAS DETECTED. TWO ATTEMPTS TO SEAL THE ENDOLEAK WITH BALLOONING WERE UNSUCCESSFUL. THE PHYSICIAN DECIDED TO CONVERT THE PATIENT TO AN OPEN REPAIR USING AN ATRIUM SURGICAL GRAFT. THE PATIENT TOLERATED THE PROCEDURE AND IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL STENT GRAFT EXTENSION MIH ENDOLOGIX, INC 34-34-80LE W10-0089-021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention