BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4241758 · Received November 10, 2014

    Report

    Report Number
    2031527-2014-00348
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 12 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, TWO SUPRARENAL AORTIC EXTENSIONS AND ONE INFRARENAL AORTIC EXTENSION AN ENDOLEAK WAS IDENTIFIED. THE PATIENT HAD A FOLLOW-UP VISIT ON (B)(6) 2014 AND THE COMPUTED TOMOGRAPHY SCAN REVEALED THERE WAS AN ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO BRING THE PATIENT IN ON (B)(6) TO SEAL THE ENDOLEAK WITH A BIFURCATED DEVICE. THE PATIENT IS REPORTEDLY DOING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723987 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-120/I16-40 1111680-017

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention