BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18302209 · Received December 11, 2023

    Report

    Report Number
    3015365904-2023-00003
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    November 14, 2023
    Report Date
    November 16, 2023
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WAS UNABLE TO BE PERFORMED AS THE DEVICE REMAINED IN THE AMPUTATION. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED OCCLUSION OF THE RIGHT TORUS STENT, ADDITIONAL ENDOVASCULAR PROCEDURE ((B)(6) 2023), RIGHT LOWER LIMB ISCHEMIA AND AMPUTATION OF THE RIGHT LOWER EXTREMITY ((B)(6) 2023) COMPLAINTS ARE CONFIRMED. THE COMPLAINT IS MOST LIKELY ANATOMY RELATED DUE TO THE PATIENT HAVING HYPERCOAGULABILITY WITH DEEP VEIN THROMBOSIS IN THE RIGHT POPLITEAL VEIN AND WAS BEING TREATED WITH BLOOD THINNERS. IT IS LIKELY THIS CONTRIBUTED TO THE REPORTED EVENTS. THE PROCEDURE RELATED HARMS ARE TWO ADDITIONAL PROCEDURES ((B)(6) 2023: RIGHT COMMON FEMORAL ARTERY ENDARTERECTOMY WITH PATCH ANGIOPLASTY, (B)(6) 2023: REPEAT OPEN THROMBECTOMY OF RIGHT COMMON FEMORAL ARTERY. IT WAS REPORTED THAT PATIENT INITIALLY WAS NOT PLACED ON BLOOD THINNERS POST INDEX PROCEDURE. HE WAS PLACED ON BLOOD THINNERS POST OPERATIVELY, BUT IT WAS REPORTED HE MAY NOT HAVE BEEN TAKING THEM. THIS COULD HAVE CONTRIBUTED TO THE REPORTED EVENT, BUT THAT IS UNCLEAR. THE FINAL PATIENT STATUS WAS REPORTED AS BEING DISCHARGED TO INPATIENT REHABILITATION ON HOSPITAL DAY 24. 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: D4: LOT EXPIRATION DATE ¿ CORRECTED. D4: UDI # - CORRECTED. G3: AWARENESS DATE ¿ UPDATED. H4: RELEASE DATE - CORRECTED. H6: HEALTH EFFECT - IMPACT CODE ¿ REMOVE 4614. 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 AS THE PATIENT'S LEG WAS AMPUTATED. 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 DISCARDED BY THE HOSPITAL

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR PERIPHERAL ARTERIAL DISEASE ON (B)(6) 2023 WITH THE IMPLANT OF THREE (3) TORUS PERIPHERAL STENT GRAFTS. ON (B)(6) 2023, THE PATIENT WAS STILL AN INPATIENT AND COMPLAINED OF POSTERIOR KNEE PAIN. AN ULTRASOUND SHOWED DEEP VEIN THROMBOSIS OF THE POPLITEAL VEIN (NON-DEVICE RELATED). REPORTEDLY, THE PATIENT WAS NOT STARTED ON ELIQUIS OR XARELTO POST-PROCEDURE. THE PATIENT IS NOW TAKING ELIQUIS 5MG TWO TIMES A DAY. THE PATIENT WILL CONTINUE TO BE MONITORED. REPORTEDLY, THE PATIENT WAS EXPERIENCING PSYCHIATRIC ISSUES AND WAS POSSIBLY NOT TAKING THEIR MEDICATION(S). THE TORUS PERIPHERAL STENT GRAFTS RE-OCCLUDED. REINTERVENTION WAS PERFORMED ON (B)(6) 2023, TO TREAT THE OCCLUDED TORUS PERIPHERAL STENT GRAFTS. THE PHYSICIAN PERFORMED A CUTDOWN AND USED AN EDWARDS (NON-ENDOLOGIX) FOGARTY BALLOON TO PULL OUT THE THROMBUS. UNFORTUNATELY, THE CLOT SHOWERED DOWN BELOW THE KNEE AND KNOCKED OFF FLOW TO THE PATIENT'S FOOT. BELOW THE KNEE AMPUTATION WAS PERFORMED ON (B)(6) 2023. THE PATIENT IS REPORTED TO BE OUT OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845894 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X200 M0085-07

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Disability TORUS PERIPHERAL STENT GRAFT (LN M0074-25)| TORUS PERIPHERAL STENT GRAFT (LN M0076-09)