BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 2193529 · Received August 5, 2011

    Report

    Report Number
    2031527-2011-00045
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. USE OF DEVICE WITH ANEURYSM NECK ANGLE GREATER THAN 60 DEGREES IS CONSIDERED OFF-LABEL PER INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PATIENT IMPLANT ON (B)(6) 2011 OF A BIFURCATED DEVICE AND AN AORTIC EXTENSION. ON (B)(6) 2011 THE PATIENT PRESENT IN THE EMERGENCY ROOM WITH ABDOMEN PAIN, A COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011, THE PATIENT WAS TREATED WITH AN AORTIC EXTENSION WHICH CORRECTED THE ENDOLEAK. IT WAS REPORTED AT TIME OF INITIAL IMPLANT THE PATIENT'S PROXIMAL NECK ANGLE WAS GREATER THAN 60 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-120RLE W11-2516-013

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention