BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 19624396 · Received June 27, 2024

    Report

    Report Number
    3015365904-2024-00013
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    June 11, 2024
    Report Date
    June 12, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946416
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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 THE STENT OCCLUSION WITH ADDITIONAL ENDOVASCULAR PROCEDURE COMPLAINT IS CONFIRMED. THE STENT MIGRATION COMPLAINT IS UNCONFIRMED. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL ASSESSMENT ALSO DETERMINED AN INFECTION (SEPSIS) OCCURRED THAT WAS NOT IN THE EVENT AS REPORTED. THE SEPSIS WAS DISCOVERED DURING A REVIEW OF THE DISCHARGE SUMMARY DATED (B)(6) 2024. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED. NO PROCEDURE RELATED HARMS FOR THIS COMPLAINT WERE IDENTIFIED. THERE WAS CONCOMITANT NON-ENDOLOGIX PRODUCT USE DURING THE INDEX PROCEDURE, IT IS UNCLEAR IF THIS CONTRIBUTED TO THE REPORTED OCCLUSION. ON (B)(6) 2024 IT APPEARED THE STENT HAD MIGRATION BUT UPON REVIEW IT APPEARED THIS WAS LIKELY DUE TO GUIDEWIRE PLACEMENT AND ANGIOPLASTY DONE ON (B)(6) 2024. THE PATIENT HAD 100% OCCLUSION OF THE POSTERIOR AND ANTERIOR ARTERIES PRIOR TO INDEX. THESE OCCLUSIONS WERE TREATED AT THE TIME OF THE INDEX PROCEDURE. THIS DISTAL DISEASE MAY HAVE CONTRIBUTED TO THE REPORTED OCCLUSION BUT THAT COULD NOT BE CONCLUSIVELY DETERMINED. THE FINAL PATIENT STATUS WAS REPORTED TO BE DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2024. 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.

    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.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR LEFT LEG PERIPHERAL ARTERIAL DISEASE WITH THE IMPLANT OF FOUR (4) DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) ON (B)(6) 2024. REPORTEDLY, AT THE INITIAL PROCEDURE, THE PHYSICIAN THOUGHT THE MOST PROXIMAL DETOUR PSG LANDED A BIT LOW AND OPTED TO DEPLOY A GORE (NON-ENDOLOGIX) VIABAHN 7X5MM. THE FINAL IMAGES LOOKED GOOD, AND THE PATIENT WENT HOME THE SAME DAY. ON TUESDAY, (B)(6) 2024, THE PATIENT PRESENTED EMERGENTLY WITH LEG PAIN. THE ON-CALL CARDIOLOGIST HAD TROUBLE GETTING A WIRE DOWN THROUGH THE STENTS BUT ULTIMATELY WAS ABLE TO DO SO AND BALLOONED. THE STENTS HAD THROMBOSED. THE PATIENT WAS PLACED ON TISSUE PLASMINOGEN ACTIVATOR (TPA) AND WAS DOING WELL. ON WEDNESDAY, (B)(6) 2024, THE IMPLANTING PHYSICIAN SAW THE PATIENT AGAIN IN THE LAB. IT LOOKED LIKE THE STENT HAD MIGRATED; HOWEVER, AFTER REVIEWING THE ANGIOGRAM FROM THE PREVIOUS DAY THE IMPLANT MOVEMENT WAS LIKELY CAUSED BY TRYING TO GET THE WIRE DOWN AND BALLOONING. THE PHYSICIAN STATED THAT THE PATIENT HAD DISEASE DISTAL TO THE TORUS PSG STENT AND THIS MAY HAVE CAUSED THE ISSUE OR THAT THE MOST PROXIMAL STENT (GORE (NON-ENDOLOGIX) VIABAHN) WAS UNDERSIZED. THE PHYSICIAN ELECTED TO DEPLOY A GORE (NON-ENDOLOGIX) VIABAHN 8X5MM STENT. THE PATIENT WAS REPORTED TO BE DOING WELL POST-SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430129 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-5.5X200 M048113 00860008946416

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H GORE (NON-ENDOLOGIX) VIABAHN (LN UNK).| TORUS PERIPHERAL STENT GRAFT (LN M0126-07).| TORUS PERIPHERAL STENT GRAFT (LN M0190-25).| TORUS PERIPHERAL STENT GRAFT (LN M0407-16).| TORUS PERIPHERAL STENT GRAFT (LN M0510-07).