BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18959257 · Received March 22, 2024

    Report

    Report Number
    3015365904-2024-00006
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 22, 2024
    Report Date
    February 22, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946416
    PMA / PMN Number
    P220021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REVEALS PARTIAL STENT DEPLOYMENT OF 0.05MM WHICH RESULTED IN IT BECOMING LODGED BETWEEN THE OUTER AND INNER SHAFTS. UPON DISSECTION OF THE TRI-AXIAL SHAFT, IT WAS DISCOVERED THAT THE OUTER SHAFT HAD SUFFERED A CLEAR BREAKAGE 12 INCHES AWAY FROM THE LATCH. A KINK WAS IDENTIFIED ON THE HYPO TUBE 11 INCHES FROM THE LATCH. DUE TO THE DEVICE HAVING BEEN OPENED AND MANIPULATED BEFORE IT WAS RECEIVED, IT IS NOT FEASIBLE TO PINPOINT THE PRECISE ROOT CAUSE OF THIS FAILURE. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE DEVICE DAMAGE DURING USE (BROKEN STENT DEPLOYMENT), PARTIAL DEPLOYMENT (STENT NOT IMPLANTED) COMPLAINTS ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS FOR THIS COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. 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. THIS AND SIMILAR ADVERSE EVENT/INCIDENT WILL CONTINUE TO BE MONITORED. CORRECTIONS: G3: AWARENESS DATE ¿ UPDATED H6: INVESTIGATION TYPE CODES - REMOVE 4118. H6: INVESTIGATION FINDING CODES - REMOVE CODE 3233. H6: INVESTIGATION CONCLUSION CODES - REMOVE CODE 11.

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT ARE EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, THEY HAVE NOT YET BEEN RECEIVED. 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 IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR LEFT LEG PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2024. DURING DEPLOYMENT OF THE FIRST DETOUR TORUS PERIPHERAL STENT GRAFT (PSG) (5.5X200MM) THE STENT DEPLOYMENT BROKE HALFWAY THROUGH THE DEPLOYMENT AND THE STENT DID NOT FULLY DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SAFELY COMPLETED WITH THE IMPLANT OF FOUR TORUS PSG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553250 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-5.5X200 M0221-23 00860008946416

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other