BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 20725795 · Received November 19, 2024

    Report

    Report Number
    3015365904-2024-00018
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    November 14, 2024
    Report Date
    November 14, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946478
    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 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 THE OCCLUSION OF THE LEFT LIMB TORUS STENT IS UNCONFIRMED. THE ISCHEMIA OF THE LEFT LOWER EXTREMITY AND ADDITIONAL ENDOVASCULAR PROCEDURE COMPLAINTS ARE CONFIRMED. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF COMPLAINT COULD NOT BE DETERMINED. PROCEDURE RELATED HARMS FOR THIS COMPLAINT COULD NOT BE DETERMINED. IT WAS REPORTED THAT THROMBUS WAS PRESENT AT THE END OF THE GRAFT. THIS LIKELY CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, THE REASON FOR THE DEVELOPMENT OF THE THROMBUS REMAINS UNCLEAR. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME AND DOING VERY WELL. 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: B5: DESCRIBE EVENT OR PROBLEM - UPDATED. 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.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR LEFT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023. THREE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) WERE SUCCESSFULLY IMPLANTED. THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2024, WITH ISCHEMIC PAIN IN LEFT LEG/FOOT. THE COMPUTED TOMOGRAPHY SHOWED THAT THE TORU GRAFT WAS DOWN. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR AN ANGIOGRAM. THE PHYSICIAN WAS ABLE TO CROSS DOWN DISTAL TO THE GRAFT ABOVE TIBIAL TRUNK. THROMBUS WAS IDENTIFIED AT THE END OF THE GRAFT. NO OTHER IMMEDIATE VISUAL ISSUES WERE SEEN WITH THE GRAFTS. THE PATIENT WAS ADMINISTERED AN OVERNIGHT LYSIS TREATMENT, AND AN EXPRESS (BOSTON SCIENTIFIC) STENT PLACED AT THE SUPERFICIAL FEMORAL ARTERY AND THE PROFUNDA. THE PATIENT WAS REPORTEDLY COMPLIANT, AND ON PLAVIX AND COUMADIN WITH INR 1.9. THE PATIENT WAS STABLE POST-REINTERVENTION.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR LEFT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023. THREE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) WERE SUCCESSFULLY IMPLANTED. IT WAS REPORTED ON (B)(6) 2024, THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH ISCHEMIC PAIN IN LEFT LEG/FOOT. THE COMPUTED TOMOGRAPHY SHOWED THAT THE TORU GRAFT WAS DOWN. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR AN ANGIOGRAM. THE PHYSICIAN WAS ABLE TO CROSS DOWN DISTAL TO THE GRAFT ABOVE TIBIAL TRUNK. THROMBUS WAS IDENTIFIED AT THE END OF THE GRAFT. NO OTHER IMMEDIATE VISUAL ISSUES WERE SEEN WITH THE GRAFTS. THE PATIENT WAS ADMINISTERED AN OVERNIGHT LYSIS TREATMENT. THE PATIENT WAS REPORTEDLY COMPLIANT, AND ON PLAVIX AND COUMADIN WITH INR 1.9. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938400 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X200 M008513 00860008946478

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention| H DETOUR PERIPHERAL STENT GRAFT (LN M007528)| DETOUR PERIPHERAL STENT GRAFT (LN M011709)