BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 22877101 · Received August 22, 2025

    Report

    Report Number
    3015365904-2025-00006
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    July 29, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946478
    PMA / PMN Number
    P220021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, PATIENT MEDICAL RECORDS AND RADIOLOGY RECORDS HAVE BEEN RECEIVED FOR EVALUATION. HOWEVER, THE DEVICE EVALUATION AND CLINICAL ANALYSIS HAVE NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT-RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING ARE MADE. 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. ENDOLOGIX RECEIVED ONE (1) DETOUR SYSTEM TORUS DELIVERY SYSTEM WITH A PARTIALLY DEPLOYED STENT THAT WAS RETURNED FOR EVALUATION. THE DEVICE WAS SHIPPED IN A LARGE SHIPPING BOX. THE DELIVERY SYSTEM WAS RETURNED IN A RED PLASTIC BAG, WITH A SEALED SILVER BAG, WITHIN ANOTHER RED BIOHAZARD BAG. THERE IS BLOOD RESIDUE PRESENT IN THE PLASTIC BAG, ON THE DELIVERY SYSTEM, AND ON THE PERIPHERAL STENT GRAFT. THE DEVICE WAS DECONTAMINATED AND SHIPPED TO MILPITAS FOR THE SAMPLE EVALUATION. THE EVALUATION WAS COMPLETED. THE RETURNED DEVICE EXHIBITED A PARTIALLY DEPLOYED STENT GRAFT. UPON INSPECTION, IT WAS OBSERVED THAT THE SGDS DEPLOYMENT KNOB LACKED TENSION. MANUAL EXTRACTION OF THE STENT GRAFT WAS PERFORMED, FOLLOWED BY CUTTING THE TRIAXIAL SHAFT. FURTHER INSPECTION REVEALED A BREAKAGE ON THE OUTER SHAFT, LOCATED APPROXIMATELY 440 MM FROM THE LATCH AND PULLEY. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE DAMAGED/BROKEN COMPONENT (DELIVERY SYSTEM), UNABLE TO DEPLOY (SECOND STENT-PARTIALLY DEPLOYED IN DELIVERY SYSTEM) AND ADDITIONAL ENDOVASCULAR PROCEDURE COMPLAINTS ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. USER, PROCEDURE OR ANATOMY RELATEDNESS OF COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. BASED ON THE RETURNED DEVICE EVALUATION THE POTENTIAL ROOT CAUSE OF THE OUTER SHAFT TENSILE FAILURE IS HIGHER DEPLOYMENT FORCES. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME ON HOSPITAL DAY SEVEN AND POSTOPERATIVE DAY THREE. 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 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 BEING TREATED FOR PERIPHERAL ARTERIAL DISEASE (PAD) ON (B)(6) 2025. THERE WAS AN AUDIBLE SNAP DURING THE DEPLOYMENT OF THE SECOND TORUS PERIPHERAL STENT GRAFT (PSG) WHILE THE DEPLOYMENT HANDLE WAS BEING HELD ON THE TABLE. IMMEDIATELY ALL THE TENSION OF THE DEPLOYMENT KNOB WAS GONE. CONTROL TO UNSHEATH THE STENT WAS LOST; HOWEVER, THE STENT HAD PARTIALLY DEPLOYED (APPROXIMATELY HALFWAY). THE TORUS PSG DELIVERY SYSTEM ABLE TO BE REMOVED WITH THE STENT PARTIALLY DEPLOYED. THE PLACEMENT OF THE DISTAL STENT WAS MAINTAINED ARTERY TO VEIN WITH THE USE OF A NON-ENDOLOGIX CONQUEST 10X4MM BALLOON TO TRAP IT. SEAL WAS ACHIEVED AFTER THE SUCCESSFUL DEPLOYMENT OF TWO ADDITIONAL TORUS PSG. THERE WERE NO ADVERSE EVENTS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619032 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT DELIVERY SYSTEM QWM ENDOLOGIX MILPITAS TSG-6.7X200 M122413 00860008946478

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention TORUS PERIPHERAL STENT GRAFT (LN M121506)