BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX

    MDR report key: 5386187 · Received January 22, 2016

    Report

    Report Number
    2031527-2016-00022
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    December 17, 2015
    Report Date
    December 24, 2015
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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: LIMB EXTENSION: MODEL NUMBER: 120-13/C88F SA, LOT NUMBER: 1040025-024, LOT RELEASE DATE: 11/12/2012, LOT EXPIRATION DATE: 10/31/2013. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2013 WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION. PATIENT CAME IN EMERGENTLY ON (B)(6) 2015 AND COMPUTED TOMOGRAPHY REVEALED A TYPE 3B (ABOVE AORTIC BIFURCATION) AND 3A (RIGHT LIMB SEPARATION) PATIENT AAA IS NOW 8.3CM AND RCIAA IS 4.6CM ( BETWEEN COMPONENTS ). ON (B)(6) 2015 A DIAGNOSTIC ANGIOGRAM PERFORMED AND BASED ON THE FINDINGS ( CTA AND ANGIO ), THE CASE WILL BE SCHEDULED FOR EITHER A RELINE WITH AFX OR POTENTIALLY, AN AUI WITH FEM-FEM CROSSOVER WITH COMPETITIVE DEVICE AND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45298 AFX BIFURCATED MIH ENDOLOGIX, INC. BA28-100/I16-40 1047124-041

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR