BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 5390933 · Received January 26, 2016

    Report

    Report Number
    2031527-2016-00024
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    December 29, 2015
    Report Date
    December 29, 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

    BASED ON THE CLINICAL ASSESSMENT IT WAS CONFIRMED TYPE 3B ENDOLEAK AND TYPE 3A DEVICE SEPARATION. PATIENT PRE-IMPLANT IMAGING WAS NOT PROVIDED. THE MANUFACTURING EVALUATION DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE ROOT CAUSE IS INCONCLUSIVE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. PATIENT PRE-IMPLANT IMAGES WERE NOT PROVIDED. POTENTIAL CONTRIBUTING FACTORS INCLUDE OFF LABEL USE, THE PATIENT ON ANTIPLATELET THERAPY AND PATIENT ANATOMY.

    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: SUPRARENAL AORTIC EXTENSION: MODEL NUMBER: A34-34/C100-020, LOT NUMBER: 1031801-023, LOT RELEASE DATE: (B)(6) 2012, LOT EXPIRATION DATE: 02/28/2013. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION. DURING A FOLLOW UP, COMPUTED TOMOGRAPHY SHOWED A TYPE 3A ENDOLEAK. THERE WAS A SEPARATION OF THE BIFURCATED STENT AND THE INFRARENAL EXTENSION. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL INFRARENAL TO CORRECT THE ISSUE. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48665 AFX INFRARENAL AORTO UNI-ILIAC MIH ENDOLOGIX, INC. A34-34/C80 W11-5218-008

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention