BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 20204953 · Received September 12, 2024

    Report

    Report Number
    3015365904-2024-00015
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946447
    PMA / PMN Number
    P220021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. DEVICE REMAINS IMPLANTED.

    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 THE TORUS GRAFT 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 FAILURE TO UNFOLD AND PROXIMAL MIGRATION COMPLAINTS ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED TO HOME ON POSTOPERATIVE DAY ONE. 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.

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TREATED FOR SUPERFICIAL FEMORAL ARTERY DISEASE ON (B)(6) 2024. A 5.5X200MM DETOUR TORUS PERIPHERAL STENT GRAFT (PSG) WAS DEPLOYED WITHOUT ISSUE. THE 6X200MM TORUS PSG WAS DEPLOYED BUT DIDN'T EXPAND. THIS CAUSED THE 6X200MM TORUS PSG TO MIGRATE PROXIMALLY LEAVING ONLY 2CM OF OVERLAP. A 6.7X100MM TORUS PSG WAS INSERTED AND DELIVERED THROUGH THE UNDER-DEPLOYED 6X200MM TO CREATE SEAL DISTALLY BETWEEN THE 5.5X200MM TORUS PSG AND THE UNDER-DEPLOYED 6X200MM TORUS PSG. HOWEVER, THE 6X200MM TORUS PSG CAUGHT ON THE 6.7X100MM TORUS PSG DELIVERY SYSTEM AND MIGRATED DISTALLY, BUT STOPPED MIGRATING AFTER THE PHYSICIAN DID SOME AGITATION OF THE DELIVERY SYSTEM. A 6.7X150MM TORUS PSG WAS USED TO ENGAGE THE PROXIMAL PORTION OF THE UNDER-DEPLOYED 6X200 TORUS PSG AND FINALLY A 6.7X200MM TORUS PSG WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505322 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.0X200 M1074-18 00860008946447

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Unknown Required Intervention TORUS PERIPHERAL STENT GRAFT (LN M083607)| TORUS PERIPHERAL STENT GRAFT (LN M087011)| TORUS PERIPHERAL STENT GRAFT (LN M100926)| TORUS PERIPHERAL STENT GRAFT (LN M115515)