BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18847029 · Received March 6, 2024

    Report

    Report Number
    3015365904-2024-00005
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 14, 2024
    Report Date
    February 14, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946478
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION. 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.

    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 DEVICE DAMAGE DURING USE (DEPLOYMENT WHEEL FAILED TO DEPLOY 2/3 OF THE WAY) SURGICAL CONVERSION AND EXPLANT 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 FOR THIS COMPLAINT WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED AS HAVING GOOD FLOW THROUGH PATENT GRAFT. 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 TREATED FOR RIGHT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2024, WITH THE IMPLANT OF THE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT (PSG). DURING DEPLOYMENT OF THE 6.7MM X 200MM DETOUR TORUS PSG, THE DEPLOYMENT WHEEL FAILED TO DEPLOY 2/3 OF THE WAY. THE PATIENT WAS TRANSFERRED FROM THE CATH LAP TO THE OPERATING ROOM (OR) FOR SURGICAL REMOVAL OF THE DEVICE. ONCE REMOVED, ACCESS WAS KEPT FROM THE ORIGINAL PROCEDURE AND PERCUTANEOUS TRANSMURAL ARTERIAL BYPASS (PTAB) WAS COMPLETED IN THE OR. THERE WERE NO OTHER COMPLICATIONS NOTED OR REPORTED. TWO DAYS POST-PROCEDURE THE PATIENT REPORTEDLY HAD POSITIVE FLOW TO THE LOWER EXTREMITIES AND PTAB WAS PATENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117619 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X200 MO107-02 00860008946478

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention