BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18968384 · Received March 25, 2024

    Report

    Report Number
    3015365904-2024-00007
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    March 1, 2024
    Report Date
    March 4, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946416
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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 (RIGHT LEG LIMB) OCCLUSION, ADDITIONAL SURGICAL PROCEDURE (FEMORAL-TIBIAL BYPASS) AND RIGHT LIMB AMPUTATION 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. IT WAS REPORTED THAT THE PATIENT WAS NON-COMPLIANT WITH FOLLOW UP CARE AND PRESCRIBED ANTICOAGULATION. THIS MAY HAVE CONTRIBUTED TO THE RIGHT LEG LIMB OCCLUSION BUT COULD NOT CONCLUSIVELY BE DETERMINED. THE FINAL PATIENT STATUS WAS NOT REPORTED. 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 AS THE PATENT LEG WAS AMPUTATED AND REMAIN IMPLANTED IN THE AMPUTATION. 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. H6: HEALTH EFFECT - IMPACT CODE: ADD 4626 AMPUTATION H3 OTHER TEXT : DEVICE REMAINED IN AMPUTATION

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR RIGHT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023. THREE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) WERE SUCCESSFULLY IMPLANTED. THE FIRST WEEKEND IN (B)(6) 2024, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AFTER TWO WEEKS OF FOOT PAIN. THE PATIENT WAS ADMITTED AND PLACED ON LYSIS FOR TWO DAYS. THE TORUS PSG REMAINED FULLY OCCLUDED. A FEMORAL-TIBIAL BYPASS WAS PERFORMED ON (B)(6) 2024. THE PATIENT WAS STABLE WITHOUT IMPROVEMENT TO THE LEG AS IT REMAINED MOTTLED AND THE SECONDARY BYPASS CLOSED. THE PATIENT¿S LEG WAS AMPUTATED ON (B)(6) 2024. REPORTEDLY, THE PATIENT WAS NOT COMPLIANT AND DID NOT COME IN FOR FOLLOW-UPS OR REPORT ANY ISSUES UNTIL THEY PRESENTED TO THE ER. THE PATIENT REPORTED THAT THEY COMPLETED THE FIRST FILL OF ELIQUIS; HOWEVER, DID NOT REFILL IT AS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-5.5X200 M007612 00860008946416

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Disability| H TORUS PERIPHERAL STENT GRAFT (LN M0095-01)| TORUS PERIPHERAL STENT GRAFT (LN M0108-16)