BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 5345548 · Received January 5, 2016

    Report

    Report Number
    2031527-2015-00522
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL DEVICE: MODEL 20-25-65S LIMB AORTIC EXTENSION, LOT: W09-0819-011, REL. DATE: (B)(6) 2009 EXP. DATE: 2/28/2010. DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED, A SUPRARENAL, AND TWO LIMB EXTENSIONS. UPON FOLLOW UP,COMPUTED TOMOGRAPHY REVEALED PATIENT WITH AN ECTATIC ILIAC ANEURYSM WHICH IT HAD GROWN. PHYSICIAN ELECTED TO IMPLANT 4 LIMB EXTENSIONS. PATIENT IS NOW STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4666 AFX LIMB AORTIC EXTENSION MIH ENDOLOGIX, INC. IS20-25/C55 W11-0498-007

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention