BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7444233 · Received April 19, 2018

    Report

    Report Number
    2031527-2018-00270
    Event Type
    Injury
    Date Received
    April 19, 2018
    Date of Event
    December 15, 2016
    Report Date
    April 12, 2018
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE INITIAL MDR IT WAS DETERMINED THAT THIS WAS A DUPLICATE CASE THAT WAS PREVIOUSLY SUBMITTED UNDER MFR# 2031527-2017-00066; THEREFORE, MFR# 2031527-2018-00270 SHOULD NOT HAVE BEEN SUBMITTED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR IT WAS DETERMINED THAT THIS WAS A DUPLICATE CASE THAT WAS PREVIOUSLY SUBMITTED UNDER MFR# 2031527-2017-00066; THEREFORE, MFR# 2031527-2018-00270 SHOULD NOT HAVE BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER TIME THAT IS PERTINENT TO THIS EVENT, A FOLLOW-UP REPORT WILL THEN BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND SUPRARENAL AORTIC EXTENSION ON (B)(6) 2017. ON A LATER DATE, AN EXPANDING ABDOMINAL AROTIC ANEURYSM WAS IDENTIFIED WITH A TYPE 3A OR 3B ENDOLEAK PER ANGIOGRAPHY. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON (B)(6) 2017 AND THE PATIENT WAS RELINED BY IMPLANTING WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288101 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX INC. BA25-110/I20-30 1200177-019

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention AFX-BIFURCATED STENT GRAFT - LOT 1200177019| AFX-SUPRARENAL AORTIC EXTENSION - LOT 1056067008