BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 19483098 · Received June 7, 2024

    Report

    Report Number
    3015365904-2024-00012
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 30, 2024
    Report Date
    May 30, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946478
    PMA / PMN Number
    P220021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DELIVERY SYSTEM (LN M042414) IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS 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.

    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 RETURNED DETOUR TORUS PERIPHERAL STENT GRAFT DELIVERY SYSTEM WAS PERFORMED. UPON EVALUATION OF THE DEVICE, A BREAKAGE ON THE OUTER SHAFT WAS OBSERVED APPROXIMATELY 10 INCHES FROM THE HANDLE, AND HALF OF THE STENT GRAFT HAD ALREADY BEEN DEPLOYED. THE ROOT CAUSE REMAINS UNKNOWN, AS THE DEVICE ARRIVED PRE-OPENED. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE DIFFICULTY TO ADVANCE AND MALPOSITION OF THE FIRST TORUS STENT (6.0X200CM) COMPLAINT IS CONFIRMED. THE DIFFICULTY IN ADVANCING, PARTIAL DEPLOYMENT, STENT DAMAGE DURING USE AND DIFFICULTY TO REMOVE SECOND TORUS STENT (6.7X200CM) COMPLAINTS ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. PROCEDURE RELATED HARMS WERE A COLD LEFT FOOT AT COMPLETION OF PROCEDURE. THE HIGH AORTIC BIFURCATION IN COMBINATION WITH THE CALCIFIED ANATOMY COULD HAVE CONTRIBUTED TO THE REPORTED EVENT, BUT THAT COULD NOT BE CONCLUSIVELY DETERMINED. THERE WAS A FOCAL FLOW DEFECT IN THE RIGHT EXTERNAL ILIAC THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT BUT THAT ALSO COULD NOT BE CONCLUSIVELY DETERMINED. THE FINAL PATIENT STATUS WAS REPORTED AS STABLE. 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.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR LEFT LEG SUPERFICIAL FEMORAL ARTERY ON (B)(6) 2024, WITH THE IMPLANT OF THE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT (PSG). THE DETOUR PROCEDURE WAS PROGRESSING IN A NORMAL FASHION ON THE LEFT LOWER EXTREMITY WHEN DIFFICULTY BEGAN ADVANCING THE TORUS STENT GRAFTS TO THE TARGET AREAS. THE PATIENT HAD BILATERAL ANEURYSMAL COMMON ILIAC ARTERIES, AND SOME ECCENTRIC CALCIUM THROUGHOUT THE COMMON AND EXTERNAL ILIAC ARTERIES AS WELL. AN AMPLATZ SUPER STIFF (NON-ENDOLOGIX) WIRE WAS ADVANCED INTO THE TIBIAL VESSELS AND THE FIRST TORUS PSG 6.0X200 WAS DEPLOYED SUCCESSFULLY AT THE LEVEL OF THE BOTTOM OF THE FEMUR WITH SOME MINOR DIFFICULTY ADVANCING IT OVER THE AORTIC ARCH. AS THE SECOND TORUS PSG 6.7X200 WAS BEING ADVANCED THROUGH THE SHEATH, THERE WAS SOME DIFFICULTY GETTING OVER THE BIFURCATION AGAIN, AND THEN THROUGH THE PROXIMAL ANASTOMOSIS. THE TORUS PSG 6.7X200 WAS ADVANCED TO APPROXIMATELY 7CM OF OVERLAP WITHIN THE FIRST DEPLOYED TORUS PSG. THE FIRST 5-6CM OF THE TORUS PSG 6.7X200 WAS DEPLOYED, THEN THE PHYSICIAN FELT (AND HEARD AND AUDIBLE) A POP AND STOPPED TURNING THE DEPLOYMENT KNOB. THE PERSONNEL IN THE ROOM ALL HEARD THE POP ALSO. THE PHYSICIAN BEGAN TURNING THE DEPLOYMENT KNOB AGAIN, WHICH RESULTED IN NO MOVEMENT OF THE STENT GRAFT DELIVERY SYSTEM. THE DECISION WAS MADE TO REMOVE THE SYSTEM FROM THE BODY BUT AS REMOVAL WAS ATTEMPTED THE FIRST TORUS PSG 6.0X200 BEGAN TO MOVE WITH THE TORUS PSG 6.7X200 BEING REMOVED. AT THIS TIME THE PHYSICIAN DECIDED TO GO AHEAD AND REMOVE THE SYSTEM AND TRY TO KEEP THE WIRE PARKED IN THE TIBIALS BUT WAS UNSUCCESSFUL. THE TORUS PSG 6.7X200 DELIVERY SYSTEM WAS REMOVED BY DETACHING THE HEMOSTATIC VALVE FROM THE 8FR X 45CM TERUMO DESTINATION SHEATH AND THEN RE-ATTACHING ONCE THE SYSTEM WAS REMOVED. THE OUTER SHAFT OF THE TORUS PSG 6.7X200 BROKE AT THE PROXIMAL MARKER. THE FIRST TORUS PSG 6.0X200 THAT WAS DEPLOYED IN THE POPLITEAL ARTERY WAS PULLED BACK INTO THE FEMORAL VEIN DURING THE REMOVAL OF THE TORUS PSG 6.7X200. THE DECISION WAS MADE TO ABANDON THE PROCEDURE AT THIS TIME, AND THE PHYSICIAN DECIDED TO SNARE THE TORUS PSG 6.0X200 AND PULL IT DOWN INTO THE AREA OF THE POPLITEAL VEIN TO POTENTIALLY PREVENT MIGRATION UP INTO THE ILIAC VEIN. ANGIOGRAMS WERE PERFORMED TO ASSESS THE ARTERIAL BLOOD FLOW IN THE LEFT LEG, WHICH WAS UNCHANGED FROM PRIOR TO THE BEGINNING OF THE PROCEDURE. ANGIOGRAMS WERE PERFORMED ON THE RIGHT LEG AS WELL AND IT WAS DETERMINED TO BALLOON AND STENT THE CONTRALATERAL EXTERNAL ILIAC ARTERY. THE PATIENT WAS REPORTED TO BE STABLE AND EXPECTED TO BE RELEASED ONE- OR TWO-DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150283 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X200 M042414 00860008946478

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention TORUS PERIPHERAL STENT GRAFT (LN M0605-26)