BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1491454 · Received September 29, 2009

    Report

    Report Number
    2031527-2009-00120
    Event Type
    Injury
    Date Received
    September 29, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 29, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PHYSICIAN LOST GUIDEWIRE ACCESS DURING PROCEDURE.

    Description of Event or Problem · 1

    PT PRESENTED WITH 9-10MM ACCESS VESSELS, TIGHT DISTAL AORTA (12MM). ACCESS AND DEPLOYMENT OF A 25-16-120BL BIFURCATED DEVICE WAS UNEVENTFUL. DURING MANIPULATIONS TO PREPARE FOR THE PROXIMAL EXTENSION, GUIDEWIRE ACCESS WAS LOST. A CODA BALLOON WAS USED TO ENSURE CENTRAL LUMEN, THE GUIDEWIRE WAS READVANCED, THE DILATOR AND INTRODUCER SHEATH WERE READVANCED INTO POSITION. WHEN THE PROXIMAL EXTENSION WAS DEPLOYED, THE INTRODUCER SHEATH WAS INADVERTENTLY PULLED INTO THE LIMB OF THE BIFURCATED STENT GRAFT. ATTEMPTS WITH BALLOONS AND MANIPULATIONS TO GET THE FRONT TIP THROUGH THE INTRODUCER SHEATH WERE UNSUCCESSFUL AS IT KEPT CATCHING ON THE STENT STRUTS. DURING BALLOONING ATTEMPT, THE INTRODUCER SHEATH PULLED OUT OF THE BIFURCATED LIMB AND INTO THE ILIAC. IT WAS READVANCED TO THE LOCATION WHERE THE FRONT TIP KEP CATCHING, AND ABLE TO RETRACT THE FRONT TIP. WHEN REMOVING THE ENTIRE SYSTEM, THE COMMON FEMORAL WAS INADVERTENTLY PERFORATED BY THE SHEATH, AND WAS RESOLVED WITH A PATCH. THE PROCEDURE WAS CLOSED WITH GOOD RESULTS. AFTER THE PROCEDURE, THE REP DISCUSSED THE IMPORTANT OF MAINTAINING GUIDEWIRE ACCESS AT ALL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-120BL W09-0303-008

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention