BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYS

    MDR report key: 1416333 · Received July 15, 2009

    Report

    Report Number
    2031527-2009-00072
    Event Type
    Injury
    Date Received
    July 15, 2009
    Date of Event
    June 11, 2009
    Report Date
    June 14, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECOND PROXIMAL CUFF EXTENSION IMPLANTED: MODEL NUMBER 28-28-75L; LOT NUMBER W08-1760-030; EXPIRATION DATE 08/01/2011. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO DETERMINE WHETHER THE SAC SHRINKAGE CONTRIBUTED TO THE ENDOLEAKS. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IN 2009, PT IMPLANT OF A 25-16-120BL BIFURCATED DEVICE AND TWO 25-25-55L PROXIMAL CUFF EXTENSIONS. FOLLOW UP CT REVEALED A POSSIBLE PROXIMAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK. NONETHELESS, THERE WAS ABOUT 8 MM SAC SHRINKAGE. AT APPROXIMATELY 5 MONTHS LATER, THE PT WAS TREATED WITH A 34-34-80L PROXIMAL CUFF EXTENSION, THE TYPE I ENDOLEAK WAS RESOLVED. THE TYPE II STILL REMAINED, AND THE PT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYS INFRARENAL CUFF EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 25-25-55L W07-2331-006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention