BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX2

    MDR report key: 18136826 · Received November 14, 2023

    Report

    Report Number
    3011063223-2023-00031
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    October 26, 2023
    Report Date
    October 30, 2023
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009014870
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, IT IS ENDOLOGIX PRACTICE TO MAKE AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT-RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING. AN EVALUATION OF THE MANUFACTURING RECORD WAS COMPLETED. A REVIEW OF THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION SHOWS THE DEVICE TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION BECAUSE THE DEVICE REMAINS IMPLANTED. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE RUPTURE (ILIAC); POSSIBLE TYPE IIIA OR TYPE IIIB ENDOLEAK; REINTERVENTION COMPLAINTS ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS FOR THIS COMPLAINT WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS NOT REPORTED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED ADVERSE EVENT/INCIDENT IS PLANNED. HOWEVER, SHOULD ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OUTCOME BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS AND SIMILAR ADVERSE EVENTS/INCIDENTS. DEVICE ITERATION IS AFX2.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR AN EMERGENCY ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2023. SEVERAL GORE (NON-ENDOLOGIX) VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) HAD PREVIOUSLY BEEN IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY (CIA) TO THE EXTERNAL ILIAC ARTERY (EIA). DURING THIS EVAR, AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED FROM THE LEFT ACCESS AND AN ADDITIONAL VBX STENT GRAFT WAS ALSO ADDED. (THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM). ON (B)(6) 2023 AN EMERGENCY EVAR WAS PERFORMED DUE TO ANEURYSM RUPTURE. REPORTEDLY, IT WAS POSSIBLY DUE TO TYPE IIIA ENDOLEAK DUE TO THE VBX STENT GRAFT MIGRATION OR A TYPE IIIB ENDOLEAK OF THE AFX2 BIFURCATED STENT GRAFT; HOWEVER, THIS WAS NOT DEFINITIVELY DETERMINED. A MEDTRONIC (NON-ENDOLOGIX) ENDURANT CUFF WAS ADDED AT THE PROXIMAL PORTION, AND A VBX STENT GRAFT WAS ADDED FROM THE RIGHT CIA TO EIA. AN AFX INTRODUCER SHEATH WAS INSERTED AND AN AFX2 BIFURCATED STENT GRAFT DELIVERY SYSTEM WAS DOCKED. SMALL RESISTANCE WAS FELT WHEN DOCKING DEVICES, BUT THE SHEATH VALVE WAS CONFIRMED IN OPEN POSITION. THE PHYSICIAN ATTEMPTED TO ADVANCE THE AFX2 DELIVERY SYSTEM, BUT A STRONG RESISTANCE WAS FELT, AND THE PHYSICIAN WAS UNABLE TO ADVANCE THE AFX2 DELIVERY SYSTEM ANY FURTHER. THE PHYSICIAN WAS ALSO UNABLE TO REMOVE THE AFX2 DELIVERY SYSTEM FROM THE AFX INTRODUCER SHEATH; THEREFORE, BOTH WERE REMOVED FROM THE BODY TOGETHER. WHEN REMOVED, SIGNIFICANT AFX INTRODUCER SHEATH TIP DAMAGED WAS IDENTIFIED. THE PROCEDURE WAS COMPLETED WITH A NEW AFX INTRODUCER SHEATH AND THE SUCCESSFUL IMPLANT OF A NEW AFX2 BIFURCATED STENT GRAFT. THE FINAL PATIENT STATUS WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332023 AFX2 BIFURCATED STENT GRAFT MIH ENDOLOGIX BEA25-70/I16-30 2504911016 00818009014870

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.| GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.| GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.| GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.