BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6211862 · Received December 28, 2016

    Report

    Report Number
    2031527-2016-00593
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 23, 2016
    Report Date
    February 22, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    AT THE COMPLETION OF THE COMPLAINT INVESTIGATION, BASED ON THE INFORMATION RECEIVED, A TYPE 3A ENDOLEAK WAS REFUTED AND CONFIRMED TO BE A TYPE 3B ENDOLEAK. THE CLINICAL EVALUATION ADDITIONALLY FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; SEVERE ANGULATION OF THE CUFF ACROSS THE SUPERIOR STENT MARGIN. 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 EVENT DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT AVAILABLE FOR FURTHER EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. THERE IS NOT ENOUGH INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2013 WITH A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A TYPE 3A ENDOLEAK A COMPONENT SEPARATION BETWEEN THE MAIN BODY AND PROXIMAL EXTENSION. THE PHYSICIAN ALSO NOTED THE PATIENT HAS SIGNIFICANT AORTIC ANGULATION THAT MAY HAVE CONTRIBUTED TO THE UNINTENDED MOVEMENT OF THE STENTS. THE PATIENT HAS NOT BEEN SCHEDULED FOR A SUBSEQUENT ENDOVASCULAR PROCEDURE AT THIS TIME AND IS REPORTED TO BE IN STABLE CONDITION. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860642 AFX BIFURCATED MIH ENDOLOGIX INC. BA25-80/I16-40 1053145-016

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention AORTO UNI-ILIAC [SUPRARENAL]- 1046964-025