BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 24897497 · Received April 16, 2026

    Report

    Report Number
    3015365904-2026-00003
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946461
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2024 WITH THE IMPLANT OF FOUR TORUS GRAFTS. ON (B)(6) 2026 REINTERVENTION WAS PERFORMED TO TREAT OCCLUSION WITHIN THE TORUS STENT GRAFTS. AN ANGIOJET AND TISSUE PLASMINOGEN ACTIVATOR (TPA) WERE USED. UPON COMPLETION OF THROMBECTOMY, CONTRAST EXTRAVASATION WITHIN VEIN WAS HIGHLIGHTED ON ANGIOGRAPHY WITHIN THE TORUS STENT GRAFTS. IT WAS REPORTED THAT THE DEVICES DID NOT UNCOUPLE. TWO 6.7X200 TORUS STENTS WERE DEPLOYED FOLLOWING 7X200MM 035 PTA BALLOON. FLOW WAS COMPLETELY RESTORED WITH MORE THAN TWO VESSEL DELIVERING BLOOD TO THE FOOT. THE PATIENT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297861 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X150 M078830 00860008946461

    Patients

    Seq Age Sex Outcome Treatment
    1