BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 23802506 · Received December 15, 2025

    Report

    Report Number
    3015365904-2025-00009
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    November 24, 2025
    Report Date
    November 24, 2025
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    QWM
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE TORUS GRAFT REMAINS 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 RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUSION (THROMBUS IN TORUS STENT) AND ADDITIONAL ENDOVASCULAR PROCEDURE COMPLAINTS ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF COMPLAINT CANNOT BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. IT SHOULD BE NOTED THAT IT WAS REPORTED THAT POST-DISCHARGE COMPLIANCE WITH ANTICOAGULATION THERAPY AFTER THE INDEX PROCEDURE WAS UNCLEAR. THERE WAS POPLITEAL ARTERY STENOSIS WITH A VESSEL DIAMETER OF 3.5MM AND TIBIOPERONEAL TRUNK STENOSIS WITH A DIAMETER OF 3.0MM. THIS DISTAL SMALL VESSEL DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED RSFA STENT OCCLUSION; HOWEVER, THIS COULD NOT CONCLUSIVELY BE DETERMINED. THE FINAL PATIENT STATUS WAS REPORTED AS POSTOPERATIVE DAY THREE IN STABLE CONDITION AND DISCHARGED TO HOME ON 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. CORRECTIONS: G3: AWARENESS DATE ¿ UPDATED. H6: INVESTIGATION TYPE CODES - REMOVE CODE 4118. H6: INVESTIGATION FINDING CODES - REMOVE CODE 3233. H6: INVESTIGATION CONCLUSION CODES - REMOVE CODE 11.

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE DEVICES WILL NOT BE PERFORMED AS THEY REMAIN IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES HAVE BEEN REQUESTED FOR EVALUATION BY A CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT: DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR PERIPHERAL ARTERIAL DISEASE WITH THE IMPLANT OF THREE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) ON (B)(6) 2025. ON (B)(6) 2025 THE PATIENT WAS TREATED FOR THROMBOSIS IN THE TORUS PSG WITH A LYSIS CATHETER (IDENTIFIED AT ROUTINE FOLLOW-UP). THE PHYSICIAN ALSO PERFORMED DISTAL ANGIOPLASTY OF THE DISTAL POP. THE POST LYSIS ANGIOGRAM LOOKED WIDE OPEN AFTER TREATMENT. THE PATIENT REPORTED TO BE COMPLIANT WITH MEDICATIONS; HOWEVER, THE PHYSICIAN SUSPECTS THE PATIENT MAY NOT HAVE TAKEN MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291672 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX SANTA ROSA TSG-5.5X200 M118904

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| H TORUS PSG (LN M124518)| TORUS PSG (LN M133409)