BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18789710 · Received February 27, 2024

    Report

    Report Number
    3015365904-2024-00004
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 5, 2024
    Report Date
    February 5, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 WAS UNABLE TO BE PERFORMED AS THE DEVICE REMAINS 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 IMPLANT SEPARATION (MIDDLE AND PROXIMAL STENT) AND ADDITIONAL ENDOVASCULAR PROCEDURE (NON-ENDOLOGIX BRIDGING STENT) COMPLAINT IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THE COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. THE PROXIMAL TORUS STENT APPEARED TO RECOIL PROXIMALLY DUE TO THE ANATOMICAL SPIRAL NATURE OF THE FEMORAL VEIN. IT IS UNCLEAR IF THE ANATOMY WAS WHAT CAUSED THE IMPLANT SEPARATION. THE FINAL PATIENT STATUS WAS DISCHARGED HOME ON THE FIRST POST OPERATIVE DAY. 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.

    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.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR RIGHT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023, WITH THE IMPLANT OF THREE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG). REPORTEDLY, REINTERVENTION TO TREAT THE TORUS PSG IMPLANT SEPARATION WAS PERFORMED ON (B)(6) 2024. THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657043 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.0X200 M0095-03

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention TORUS PERIPHERAL STENT GRAFT (LN M0085-20)| TORUS PERIPHERAL STENT GRAFT (LN M0198-10)