BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6080641 · Received November 4, 2016

    Report

    Report Number
    2031527-2016-00522
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    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.

    Additional Manufacturer Narrative · 1

    AT THE COMPLETION OF THE CLINICAL EVALUATION, BASED ON THE INFORMATION RECEIVED THE FOLLOWING WERE CONFIRMED; DILATION OF THE SUPRARENAL CUFF RESULTING IN AN ENDOLEAK TYPE IIIB, INCREASED SAC GROWTH, AND STABLE PATIENT CONDITION. ADDITIONALLY THERE WAS EVIDENCE TO REASONABLY SUPPORT THE FOLLOWING OBSERVATIONS; ENDOLEAK TYPE IIIA AND COMPLETE COMPONENT SEPARATION, PLACEMENT OF A NON-ENDOLOGIX IN THE LEFT EXTERNAL ILIAC DUE TO MILD STENOSIS, 50% COLLAPSE OF THE PROXIMAL PORTION OF THE MAIN BODY STENT, AND SUBOPTIMAL POSITION OF THE SUPRARENAL CUFF. THE CLINICAL ASSESSMENT WAS BASED ON ADEQUATE PATIENT MEDICAL RECORDS, AND ADEQUATE PATIENT IMAGES. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN. DEVICES WAS NOT RETURNED AND SAMPLE EVALUATION WAS NOT COMPLETED. CLINICAL FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT; OFF LABEL USE, EXTENSIVE STENT BALLOONING, AND DILATION OF THE SUPRARENAL STENT.

    Description of Event or Problem · 1

    PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION ON (B)(6) 2013. ON (B)(6) 2016 COMPUTED TOMOGRAPHY (CT) SHOWED STENT FABRIC ON PROXIMAL EXTENSION AND MAIN BODY STRETCHED PAST DEVICE SPECIFICATIONS, A DECREASE IN OVERLAP OF THE MAIN BODY AND PROXIMAL EXTENSION, AND SAC GROWTH WITH NO OBSERVED ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE ON (B)(6) 2016 AND IMPLANTED AN ADDITIONAL BIFURCATED STENT AND TWO SUPRARENAL AORTIC EXTENSIONS. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729366 AFX BIFURCATED MIH ENDOLOGIX INC. BA25-70/I16-30 1046779-007

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SUPRARENAL AORTA UNI-ILIAC- (B)(4)