BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLINK SYSTEM

    MDR report key: 989840 · Received February 1, 2008

    Report

    Report Number
    2031527-2008-00007
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 1, 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. NO ISSUES WERE NOTED. ONE PRIOR REPORT HAS BEEN ISSUED (REF MDR #2031527-2008-006). BOTH DEVICES WERE FROM THE SAME LOT. FURTHER INVESTIGATION OF THE RETURNED DEVICE INDICATED THAT THE UV ADHESIVE BOND AT THE LOCATION OF THE LIMB SHEATH/GUIDEWIRE WAS NOT FULLY CURED WHICH COULD AFFECT THE TENSILE STRENGTH AT THAT LOCATION. BOTH THE COMPONENT FAILURE AND OPERATIONAL CONTEXT CAUSED THE EVENT.

    Description of Event or Problem · 1

    PT PRESENTED WITH SEVERE TORTUOSITY IN THE ILIAC VESSELS. DURING POSITIONING OF THE BIFURCATED DEVICE, THE PHYSICIAN WAS UNABLE TO PASS AN 0.014" GUIDEWIRE THROUGH THE CONTRALATERAL DEVICE LIMB WIRE, AND DECIDED TO GO WITHOUT IT. WHILE ATTEMPTING TO RELEASE THE CONTRALATERAL LIMB BY PULLING ON THE DEVICE LIMB WIRE, THE LIMB WIRE SEPARATED FROM THE CONTRALATERAL LIMB SHEATH RIGHT AT THE BASE OF THE SHEATH. SINCE THERE WAS NO 0.014" WIRE IN PLACE TO USE A SNARE, A RETROPERITONEAL CUTDOWN WAS PERFORMED TO RETRIEVE THE LIMB SHEATH. THE REST OF THE PROCEDURE WENT WITHOUT INCIDENT. THE PT 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 W07-2430

    Patients

    Seq Age Sex Outcome Treatment
    1 Other