BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITRAK

    MDR report key: 6123217 · Received November 22, 2016

    Report

    Report Number
    2031527-2016-00548
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    October 27, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2010. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) COMPLETED ON (B)(6) 2016 SHOWED A POTENTIAL TYPE 3A OR 3B ENDOLEAK. ON (B)(6) 2016 THE PHYSICIAN ELECTED TO RELINE THE INITIAL DEVICES BY IMPLANTING AN ADDITIONAL BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION TO SEAL THE LEAK. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772887 INTUITRAK BIFURCATED MIH ENDOLOGIX INC. 28-16-120BL W10-1608-020

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SUPRARENAL AORTA UNI-ILIAC- (B)(4)