BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 19459571 · Received June 4, 2024

    Report

    Report Number
    3015365904-2024-00011
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 15, 2024
    Report Date
    May 16, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946461
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. 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. AN EVALUATION OF THE DEVICE WAS UNABLE TO BE PERFORMED AS IT WAS NOT RETURNED TO ENDOLOGIX 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 TORUS STENT OCCLUSION, PROXIMAL TORUS STENT MIGRATION AND ADDITIONAL ENDOVASCULAR PROCEDURE COMPLAINTS ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. PROCEDURE RELATED HARMS COULD NOT BE DETERMINED. THE FINAL PATIENT STATUS IS REPORTED AS DISCHARGED HOME ON POST OPERATIVE DAY TWO AND DOING FINE POST REINTERVENTION. 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 FINDING CODES - REMOVE CODE 3233. H6: INVESTIGATION CONCLUSION CODES - REMOVE CODE 11.

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER 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.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR LEFT LEG SUPERFICIAL FEMORAL ARTERY (SFA) FEM-POP BYPASS OCCLUSION ON (B)(6) 2024, WITH THE IMPLANT OF THE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT (PSG). THE FEM-POP BYPASS OCCLUSION WAS TREATED WITH PERCUTANEOUS TRANSMURAL ARTERIAL BYPASS THROUGH THE DACRON (NON-ENDOLOGIX) GRAFT SINCE THEY COULD NOT GET INTO THE NATIVE SFA. THE 6.0X200 TORUS PSG DELIVERY SYSTEM WAS ADVANCED INTO THE 8FR SHEATH, AND DUE TO THE FORCE OF ADVANCEMENT IT WOULD NOT TRACK THROUGH THE SHEATH. THE TORUS PSG DELIVERY SYSTEM WAS REMOVED, AND THE STENT HAD PARTIALLY DEPLOYED (TWO STENT SEGMENTS) OUT OF THE DELIVERY SYSTEM. THERE WAS NO HARM TO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT HAD LEG PAIN. IT WAS IDENTIFIED THAT THE DETOUR STENT IN THE DACRON GRAFT BYPASS OCCLUDED AND THE MOST PROXIMAL 6.7 TORUS PSG MIGRATED ABOUT 2CM. THE OCCLUSION WAS TREATED WITH THROMBECTOMY AND OVERNIGHT LYTIC THERAPY. A VIABAHN (NON-ENDOLOGIX) STENT WAS DEPLOYED AT THE SFA/PROFUNDA TO REINFORCE IT AND KEEP IT OPEN. THE PATIENT WAS REPORTED TO BE DOING FINE AND WAS DISCHARGED TWO DAYS POST-REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149093 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X150 M008713 00860008946461

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention TORUS PERIPHERAL STENT GRAFT (LN M008714)| TORUS PERIPHERAL STENT GRAFT (LN M028701)| TORUS PERIPHERAL STENT GRAFT (LN M046007)