BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 23358175 · Received October 22, 2025

    Report

    Report Number
    3015365904-2025-00008
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 4, 2025
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946461
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH 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 WAS UNABLE TO BE PERFORMED AS IT REMAINS IMPLANTED IN THE PATIENT. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE TORUS PERIPHERAL STENT GRAFT SEPARATION AND ADDITIONAL ENDOVASCULAR PROCEDURE COMPLAINTS ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE COMPLAINT IS LIKELY ANATOMY RELATED AS THE PHYSICIAN ATTRIBUTED THE GRAFT MALPOSITION/SEPARATION OF THE PERIPHERAL STENT GRAFT TO ANATOMICAL TORTUOSITY OF THE SUPERFICIAL FEMORAL ARTERY AND THE ADJACENT VENOUS SYSTEM. HEAVY CALCIFICATION OF THE ILIAC VESSELS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT BUT COULD NOT CONCLUSIVELY BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. IT IS UNCLEAR WHAT THE OVERLAP BETWEEN THE STENTS WAS INITIALLY. PER THE DETOUR IFU, A MINIMUM OVERLAP OF 60MM BETWEEN ADJACENT STENT GRAFTS IS RECOMMENDED. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGE TO HOME ON HOSPITAL DAY FIVE. 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 REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR PERIPHERAL ARTERIAL DISEASE (PAD) ON (B)(6) 2025. FOUR DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) WERE IMPLANTED. PRIOR TO THE PATIENT BEING DISCHARGED, IMPLANT SEPARATION OF TWO OF THE TORUS PSG WAS IDENTIFIED. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 WITH THE IMPLANT OF THREE ADDITIONAL TORUS PSGS TO RELINE THE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242425 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X150 M065915 00860008946461

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention TORUS PSG (LN M122908)| TORUS PSG (LN M122909)| TORUS PSG (LN M122910)