BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 22913248 · Received August 28, 2025

    Report

    Report Number
    3015365904-2025-00007
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 20, 2025
    Report Date
    August 20, 2025
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946478
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT REMAIN IMPLANTED IN THE PATIENT; THEREFORE, A DEVICE EVALUATION WILL NOT BE PERFORMED. THOUGH STILL IMAGES HAVE BEEN RECEIVED, REQUESTS WILL BE MADE FOR ADDITIONAL IMAGE STUDIES AND PATIENT MEDICAL RECORDS FOR EVALUATION BY A CLINICAL SPECIALIST. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    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 STENT DISTAL MIGRATION (IMPLANT SEPARATION BETWEEN PROXIMAL 2 STENTS) AND ADDITIONAL ENDOVASCULAR PROCEDURE (THROMBECTOMY AND ADDITIONAL STENT DEPLOYED) COMPLAINTS ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE COMPLAINT IS LIKELY ANATOMY RELATED AS IT WAS REPORTED THAT THE VEIN WAS LARGE, WHICH LIKELY CONTRIBUTED TO THE STENTS LOSING OVERLAP AFTER RELAXING INTO THE ANATOMY FOLLOWING THE INDEX PROCEDURE. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED HOME ON POSTOPERATIVE DAY TWO IN STABLE CONDITION 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: B6: RELEVANT TESTS AND LAB DATA - UPDATED. G3: AWARENESS DATE ¿ UPDATED. H6: INVESTIGATION TYPE CODES ¿ REMOVE 4118. H6: INVESTIGATION FINDING CODES - REMOVE CODE 3233. H6: INVESTIGATION CONCLUSION CODES - REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR RIGHT PERIPHERAL ARTERIAL DISEASE WITH THE IMPLANT OF THREE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) ON (B)(6) 2025. THE PATIENT HAD UNDERGONE TWO PREVIOUS PROCEDURES (ATHERECTOMY AND DRUG-COATED BALLOON TREATMENT). THE LESION HAD CHRONIC TOTAL OCCLUSION WITH HEAVY CALCIFICATION. THE IMPLANT OF THE TORUS PSG WENT SMOOTHLY WITHOUT ANY OUTSIDE IFU STEPS. OVERLAPS OF TORUS PSGS WERE 6CM PER IFU. THE NEXT DAY, (B)(6) 2025, THE PATIENT HAD LEG PAIN. ANGIOGRAM WAS PERFORMED NOTING THAT THE PROXIMAL OVERLAP BETWEEN THE TWO PROXIMAL TORUS PSG (BOTH 6.7MMX200MM) HAD DISCONNECTED. THE PATIENT WAS BROUGHT TO THE CATH LAB AND A 6.7MMX150MM TORUS PSG WAS PLACED OVER THE DISCONNECT WITH APPROXIMATELY 7.5CM OF OVERLAP BETWEEN THE PREVIOUSLY IMPLANTED TORUS PSG. THIS RE-ESTABLISHED BLOOD FLOW TO THE PATIENT¿S LOWER RIGHT LEG. IT WAS REPORTED THAT THE VEIN WAS LARGE WHICH ALLOWED THE TORUS¿S TO LOSE THEIR OVERLAP AFTER RELAXING INTO THE ANATOMY POST INDEX PROCEDURE. THE PATIENT IS DOING WELL AND HAS BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834224 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X200 M127423 00860008946478

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention TORUS PERIPHERAL STENT GRAFT (LN M127425)| TORUS PERIPHERAL STENT GRAFT (LN M129125)