BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 19220269 · Received May 1, 2024

    Report

    Report Number
    3015365904-2024-00008
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    April 5, 2024
    Report Date
    April 5, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946416
    PMA / PMN Number
    P220021
    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 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, IT IS ENDOLOGIX PRACTICE TO MAKE AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING. 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. ENDOLOGIX WAS UNABLE TO PERFORM AN EVALUATION OF THE DEVICE AS IT REMAINS IMPLANTED IN THE PATIENT. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT COULD NOT BE COMPLETED. NO MEDICAL RECORDS NOR MEDICAL IMAGING RELEVANT TO THE REPORTED ADVERSE EVENT/INCIDENT WERE RECEIVED BY ENDOLOGIX. THE USER FACILITY WAS UNABLE TO PROVIDE THIS INFORMATION. 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 INCIDENTS. CORRECTIONS: 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 LEFT LEG SUPERFICIAL FEMORAL ARTERY WITH A LONG SEGMENT OF CHRONIC TOTAL OCCLUSION ON (B)(6) 2024, WITH THE IMPLANT OF THE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT (PSG). THE PATIENT HAD A PREEXISTING FEM-FEM BYPASS THAT WAS ACCESSED AS THE CONTRALATERAL ARTERIAL APPROACH. THE PROCEDURE WAS GOING VERY SMOOTHLY UP UNTIL THE POINT OF ACCIDENTAL LOSS OF WIRE IN ANTERIOR TIBIAL ARTERY CAUSING INCREASE IN PROCEDURE TIME TO RE-CANNULATE. THIS WAS DONE INADVERTENTLY BY THE FELLOW WHEN REMOVING THE DISTAL ANASTOMOSIS BALLOON. THE INITIAL 5.5X200 TORUS STENT DEPLOYED WITH NO ISSUE DISTAL IN THE P2 REGION OF THE LEFT POPLITEAL. THE 5.5X200 TORUS STENT DID NOT OPEN FULLY BUT IT DID DEPLOY APPROPRIATELY. THE STENT NOT OPENING FULLY CAUSED DIFFICULTY WHEN RETRACTING THE DELIVERY SYSTEM CAUSING THE STENT TO BE DISLODGED FROM THE DISTAL LANDING ZONE. FINAL PLACEMENT OF THE 5.5X200 ENDED UP IN THE FV WHICH RESULTED IN EXTENDED CASE TIME AND THE IMPLANTATION OF A 6.0X200 TORUS STENT DISTAL AND THROUGH THE 5.5X200 TORUS STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, WITH A FINAL STENT CONFIGURATION OF A 6.0X200 TORUS STENT INSIDE OF THE MISPOSITIONED 5.5X200 TORUS STENT FOLLOWED BY ANOTHER 6.0X200 TORUS STENT AND ENDING PROXIMALLY WITH A 6.7X200 TORUS STENT. ALL STENTS WERE POST DILATED APPROPRIATELY AND THE PATIENT DID WELL WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172319 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-5.5X200 M074407 00860008946416

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention TORUS PERIPHERAL STENT GRAFT (LN (B)(6))| TORUS PERIPHERAL STENT GRAFT (LN (B)(6))| TORUS PERIPHERAL STENT GRAFT (LN (B)(6))