BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX STENT GRAFT

    MDR report key: 2299680 · Received October 11, 2011

    Report

    Report Number
    MW5022633
    Event Type
    Injury
    Date Received
    October 11, 2011
    Date of Event
    September 12, 2011
    Report Date
    October 11, 2011
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING ENDOGRAFT REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA) USING THE ENDOLOGIX AFX ENDOVASCULAR DEVICE AND AFTER DEPLOYMENT OF THE LEFT ILIAC LIMB EXTENSION. WE WERE TRYING TO RETRIEVE THE NOSE CONE OF THE DEPLOYMENT DEVICE, WE REALIZED THERE WAS RESISTANCE TO RETRIEVAL AND THERE WAS A GIVING DURING THE PROCEDURE. THEN WE SAW ON FLUOROSCOPY THAT THE NOSE CONE HAD FRACTURED FROM THE DEPLOYMENT DEVICE. THE NOSE CONE WAS RETRIEVED ENDOVASCULARLY USING A SNARE WITH SOME DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOGIX STENT GRAFT ILIAC LIMB EXTENSION MIH ENDOLOGIX IS20-25/C55 W11-3652-008

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention