BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1142754 · Received August 27, 2008

    Report

    Report Number
    2031527-2008-00050
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DUE TO LACK OF INFORMATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT HAD IMPLANT OF A BIFURCATED DEVICE IN 2008. APPROXIMATELY ONE MONTH LATER, PATIENT COMPLAINED OF CLAUDICATION. ON ONE AND A HALF MONTHS LATER, FOLLOW UP ANGIO REVEALED THAT THE LEFT COMMON ILIAC WAS OCCLUDED. THE PATIENT WAS TREATED WITH ANGIO JET; ACCESS WITH RETROGRADE APPROACH. THROMBUS WAS STILL PRESENT, SO A THROMBOLYSIS CATHETER WAS PUT IN PLACE; INTENDED TO STAY IN PLACE AND INFUSE THE PATIENT OVERNIGHT. HOWEVER, THE CATHETER WAS INADVERTENTLY MOVED SOME TIME DURING THE NIGHT AND THE VESSEL HAD RE-OCCLUDED. THE NEXT DAY, A BALLOON WAS USED, AND THE PATIENT TOLERATED THE SECONDARY PROCEDURE WELL, WAS DISCHARGED THE DAY AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W08-0992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention