BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6192529 · Received December 21, 2016

    Report

    Report Number
    2031527-2016-00589
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AFX DEVICES. THE PATIENT WAS BENDING OVER A RECYCLE BIN WHERE THE EDGE OF THE RECYCLE BIN WAS PUSHING UP AGAINST THE PATIENT'S ABDOMEN. THE PATIENT EXPERIENCE A SEVERE PAIN AND CAME IN EMERGENTLY. COMPUTED TOMOGRAPHY ANGIOGRAM (CTA) SHOWED THE PATIENT HAD A TYPE 3B ENDOLEAK. THE PHYSICIAN DESCRIBED THE ENDOLEAK AS A POSSIBLE PUNCTURE FROM THE STENT DUE TO THE FORCE APPLIED WHILE THE PATIENT WAS BENDING OVER THE RECYCLE BIN. THE PHYSICIAN RELINED THE INITIAL DEVICES WITH A NON-ENDOLOGIX STENT TO SEAL THE ENDOLEAK. THE PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843558 AFX UNKNOWN MIH ENDOLOGIX INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention