BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6042331 · Received October 19, 2016

    Report

    Report Number
    2031527-2016-00486
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 1

    CLINICAL REVIEW FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING FACTORS CONTRIBUTED TO THE REPORTED EVENT: OFF-LABEL USAGE, PREEXISTING ENDOLEAK TYPE IA AT IMPLANT, PRE-EXISTING AORTIC DISSECTION, INCREASE IN THE INFRARENAL AORTIC ANGULATION, AND INCREASED ANGULATION OF THE LEFT ILIAC LIMB AT THE BIFURCATION. THE MANUFACTURING EVALUATION DID NOT REVEAL ANY ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED, THEREFORE NO PHYSICAL EVALUATION WAS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2012 WITH A BIFURCATED STENT, AN INFRARENAL AORTIC EXTENSION, AND THREE LIMB STENT GRAFTS. ON FOLLOW UP THE PHYSICIAN IDENTIFIED MOVEMENT OF THE PROXIMAL EXTENSION CAUSING AN ENDOLEAK. THE PATIENT HAS HAD NO REPORTED INTERVENTION AT THIS TIME. THE PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691025 AFX INFRARENAL AORTO UNI-ILIAC MIH ENDOLOGIX INC. A34-34/C100 1026641-010

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention BIFURCATED- (B)(4)| LIMB EXTENSION- (B)(4)| LIMB EXTENSION- (B)(4)| LIMB EXTENSION- (B)(4)