BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 19436608 · Received May 31, 2024

    Report

    Report Number
    3015365904-2024-00010
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 16, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 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 AS IT REMAINS IMPLANTED IN THE PATIENT. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS RIGHT TORUS STENT THROMBOSIS, ADDITIONAL ENDOVASCULAR PROCEDURE (LYSIS OF THROMBOSIS) AND ADDITIONAL SURGICAL PROCEDURE (FASCIOTOMY FOR COMPARTMENT SYNDROME) COMPLAINTS ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED AS RECOVERING. 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 SUPERFICIAL FEMORAL ARTERY (SFA) ON (B)(6) 2024, WITH THE IMPLANT OF THE DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT (PSG). DURING THE INITIAL PROCEDURE, THE TORUS PSG (6MMX150MM LOT# M049716) WAS INTRODUCED INTO THE TIBIAL PLATEAU. THE TORUS PSG WAS DEPLOYED; HOWEVER, THE NOSE CONE HAD PULLED THE TORUS PSG BACK 4CM. (THIS TORUS PSG WAS JUST BELOW THE DISTAL ANASTOMOSIS ON THE FINAL ANGIOGRAM.) THE SECOND TORUS PSG (6.7MMX200MM LOT # M044422) WAS DEPLOYED. THE THIRD TORUS PSG (6.7X100MM LOT # M044422) WAS DEPLOYED UNEVENTFULLY. ANGIOGRAM IDENTIFIED THAT AN ADDITIONAL GRAFT WAS REQUIRED TO COVER THE DISTAL ANASTOMOSIS TO THE TIBIAL PLATEAU. THE TORUS PSG (5.5MMX200MM LOT # M074414) WAS DELIVERED TO THE TIBIAL PLATEAU. THIS TORUS PSG WOULD NOT ANCHOR, AND THE NOSE CONE PULLED BACK THE COMMON FEMORAL ARTERY. THIS WAS REMEDIED BY GOING UP 3ATMS ON A 6MMX40MM BALLOON. THE BALLOON WAS PLACED JUST ABOVE THE TORUS PSG (5.5MMX200MM LOT # M074414). BY TAPPING ON THE PROXIMAL END OF GRAFT WITH THE BALLOON THE TORUS PSG WAS PUSHED BACK DOWN TO THE INTENDED LOCATION. IT WAS THEN BALLOONED WITH A 6MMX150MM BALLOON. FINAL ANGIOGRAM WAS PERFORMED, AND THE PHYSICIAN WAS HAPPY WITH THE RESULTS. REPORTEDLY, ON (B)(6) 2024, THE PATIENT PRESENTED EMERGENTLY WITH A COLD LEG AND WAS ADMITTED. IT WAS IDENTIFIED THAT THE TORUS PERCUTANEOUS TRANSMURAL ARTERIAL BYPASS GRAFT WAS THROMBOSED. THE PHYSICIAN WAS ABLE TO USE LYTICS TO OPEN THE GRAFT HOWEVER, THE PATIENT SUFFERED COMPARTMENTAL SYNDROME AND HAD FASCIOTOMIES TO RELIEVE THE PRESSURE. THERE HAS BEEN ASSOCIATED TISSUE REMOVAL DUE TO NECROSIS. THE PATIENT IS REPORTED TO BE RECOVERING IN HOSPITAL FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239501 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.0X200 M011708

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R TORUS PSG (LN M044421)| TORUS PSG (LN M044422)| TORUS PSG (LN M049716)| TORUS PSG (LN M055124)| TORUS PSG (LN M074414)