BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 23856825 · Received December 19, 2025

    Report

    Report Number
    3011063223-2025-00197
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009010223
    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. 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 IT 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 THAT THE IMPLANT MOVEMENT COMPLAINT IS UNCONFIRMED. THE RIGHT COMMON ILIAC ARTERY STENOSIS COMPLAINT IS CONFIRMED. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. A CALCIFIED PLAQUE AT THE INFERIOR MARGIN OF THE RIGHT COMMON ILIAC ARTERY STENT LIKELY CONTRIBUTED TO RIGHT COMMON ILIAC ARTERY STENOSIS. THERE WAS CONCOMITANT PRODUCT USAGE OF A NON ENDOLOGIX EXCLUDER CUFF AT INDEX MAKING THIS OFF LABEL. IT IS UNLIKELY THAT THIS CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT IS LIKELY ANATOMY RELATED. PROCEDURE RELATED HARMS COULD NOT BE DETERMINED. THE PATIENT¿S FINAL STATUS WAS REPORTED AS POOR DUE TO AN UNRELATED EVENT; CONSEQUENTLY, THE PLANNED SECONDARY PROCEDURE WAS CANCELLED. 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 H3 OTHER TEXT: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AN EXCLUDER CUFF (NON-ENDOLOGIX) ON (B)(6) 2016. IN 2023, ANKLE-BRACHIAL INDEX (ABI) WAS 1.0. IN 2024, ABI WAS 0.9. IN 2025, ABI WAS LESS THAN 0.9 AND THE PATIENT'S PULSE WAS PALPABLE BUT PERCEIVED AS SLIGHTLY WEAK. CONTRAST CT SHOWED THE DISTAL END OF THE AFX (BSG) RIGHT LEG APPEARED TO BE LEANING INWARD. AN INTERVENTION FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ADDITIONAL BARE STENT PLACEMENT WAS BEING CONSIDERED. ON (B)(6) 2025 THE PATIENTS WAS IN POOR CONDITION DUE TO ISSUES AT A SITE UNRELATED TO THIS EVENT. THE PHYSICIAN ELECTED TO NOT PERFORM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2345124 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA22-90/I16-30 1423840014 00818009010223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other EXCLUDER CUFF (NON-ENDOLOGIX)