BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18704167 · Received February 14, 2024

    Report

    Report Number
    3015365904-2024-00002
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    October 6, 2023
    Report Date
    January 24, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    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 WAS UNABLE TO BE PERFORMED AS THE DEVICE REMAINED IN THE AMPUTATION. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE DEEP VEIN THROMBOSIS COMPLAINT IS UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE INDEX PROCEDURE RELATED HARMS IDENTIFIED WERE PROLONGED PROCEDURE (7 HOURS) AND INABILITY TO CROSS EXTERNAL ILIAC WITH WIRE REQUIRING ADDITIONAL ENDOVASCULAR PROCEDURE (RIGHT COMMON FEMORAL ARTERY CUTDOWN AND ENDARTERECTOMY). THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED TO HOME ON POSTOPERATIVE DAY 4 IN STABLE CONDITION. 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. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR RIGHT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023. PRE-BALLOONING OF THE EXTERNAL ILIAC WAS PERFORMED AND THREE (3) DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) WERE IMPLANTED. ENDOLOGIX WAS NOTIFIED ON (B)(6) 2024, THAT DEEP VEIN THROMBOSIS (DVT) OR GRAFT OCCLUSION OCCURRED APPROXIMATELY TWO WEEKS POST-IMPLANT. REPORTEDLY, THE PATIENT WAS STARTED ON AN ANTICOAGULANT AT THAT TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT STATUS IS UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR RIGHT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023. PRE-BALLOONING OF THE EXTERNAL ILIAC WAS PERFORMED AND THREE (3) DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) WERE IMPLANTED. ENDOLOGIX WAS NOTIFIED ON 24 JANUARY 2024, THAT DEEP VEIN THROMBOSIS (DVT) OCCURRED APPROXIMATELY TWO WEEKS POST-IMPLANT. REPORTEDLY, THE PATIENT WAS STARTED ON AN ANTICOAGULANT AT THAT TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339359 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X150 M0075-29

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention DETOUR SYSTEM TORUS PSG (LN M0071-09).| DETOUR SYSTEM TORUS PSG (LN M0074-06).