BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18574143 · Received January 24, 2024

    Report

    Report Number
    3015365904-2024-00001
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 12, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    UDI-DI
    00860008946478
    PMA / PMN Number
    P220021
    Adverse Event
    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 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 WAS UNABLE TO BE PERFORMED AS THE DEVICE 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 OCCLUSION OF THE PROXIMAL TORUS STENT AND 2 ADDITIONAL ENDOVASCULAR PROCEDURES (NON ENDOLOGIX STENTS) 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. NO PROCEDURE RELATED HARMS WERE IDENTIFIED. NO CONTRIBUTING FACTORS IDENTIFIED. THE FINAL PATIENT STATUS WAS REPORTED AS DISCHARGED HOME ON HOSPITAL DAY FOUR, POSTOPERATIVE DAY THREE AND DAY TWO IN STABLE CONDITION. 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 LEFT LEG PERIPHERAL ARTERIAL DISEASE WITH THE IMPLANT OF THREE (3) DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS (PSG) ON (B)(6) 2023. PATIENT PRESENTED TO PRIMARY CARE/CARDIOLOGIST WITH LEFT RESTING LEG PAIN (EXACT DATE IS UNKNOWN). THE PATIENT WAS REFERRED TO THE IMPLANTING PHYSICIAN WHO SAW THE PATIENT ON (B)(6) 2024. VENOUS DUPLEX AND ANKLE BRANCH INDEX (ABI) TESTING WAS PERFORMED. ENDOLOGIX WAS NOTIFIED ON (B)(6) 2024 THAT THE PATIENT MAY HAVE ISSUE WITH THE TORUS PSG. THE PATIENT WAS ADMITTED TO THE IMPLANTING HOSPITAL ON (B)(6) 2024. DIAGNOSTIC ANGIOGRAPHY IDENTIFIED THAT THE TORUS PSG OCCLUDED. IT WAS NOTED THAT THE OCCLUSION WAS IN THE PROXIMAL TORUS PSG APPROXIMATELY 5MM BELOW THE PROFUNDA/SUPERFICIAL FEMORAL ARTERY (SFA) BIFURCATION AND THERE WERE DISTAL AREAS OF POTENTIAL OCCLUSION. RECONSTITUTION NOTED AT PATELLA DISTAL END OF STENT. A BOSTON SCIENTIFIC ANGIOJET THROMBECTOMY SYSTEM WITH LYSIS PULSES WAS PERFORMED AND THE PROXIMAL AND DISTAL AREAS OF OCCLUSION WERE BALLOONED WITH A 6X60MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. THE THROMBOSIS REMAINED. A BOSTON SCIENTIFIC EKOS ENDOVASCULAR SYSTEM WAS PLACED, AND LYSIS AND HEPARIN WERE ADMINISTERED FOR APPROXIMATELY 24 HOURS FOR THROMBOLYSIS. THE PATIENT RETURNED TO THE CATH LAB ON (B)(6) 2024. ANGIOGRAPHY SHOWED IMPROVED QUALITY OF THROMBOSIS. DISTAL BALLOONING WITH A BOSTON SCIENTIFIC 6X60MM RANGER DRUG COATED BALLOON WITH RUBICON DIRECT ADMINISTRATION LYTIC WAS PERFORMED AND THERE WAS STILL A SMALL IRREGULARITY PRESENT. A BOSTON SCIENTIFIC 6X40MM ELUVIA DRUG ELUTING STENT WAS IMPLANTED DISTALLY AND THE IRREGULARITY WAS GONE WITH A BRISK 3 VESSEL RUNOFF. PROXIMALLY, A GORE 7X29MM VBX STENT WAS IMPLANTED AT THE PROFUNDA/SFA BIFURCATION. THERE WAS BRISK FLOW THROUGHOUT. THE PROCEDURE WAS COMPLETED WITH A MINX CLOSURE PLACED. PENDING AN UPDATE ON PATIENT CONDITION POST-REINTERVENTION. IT SHOULD BE NOTED THAT THE PATIENT WAS PRESCRIBED LOW DOSE ASPIRIN AND PLAVIX. PATIENT REPORTED TO BE TAKING BOTH SINCE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478166 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X200 M0071-06 00860008946478

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Hospitalization| R DETOUR SYSTEM TORUS PSG (LN M007527)| DETOUR SYSTEM TORUS PSG (LN M011710)