BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETOUR SYSTEM TORUS

    MDR report key: 18761657 · Received February 22, 2024

    Report

    Report Number
    3015365904-2024-00003
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 30, 2024
    Report Date
    February 1, 2024
    Manufacturer
    ENDOLOGIX MILPITAS
    Product Code
    QWM
    PMA / PMN Number
    P220021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS THE DEVICE WAS IN THE AMPUTATION. 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 REMAINED IN AMPUTATION.

    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 BY ENDOLOGIX SHOWS THE LEFT ABOVE THE KNEE AMPUTATION COMPLAINT IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL ASSESSMENT DETERMINED THERE WAS AN OCCLUSION OF THE DETOUR BYPASS THAT WAS NOT IN THE EVENT AS REPORTED. THE OCCLUSION WAS DISCOVERED DURING A REVIEW OF THE OPERATIVE REPORT DATED (B)(6) 2024. THE COMPLAINT IS MOST LIKELY ANATOMY RELATED AS IT WAS REPORTED THAT THE PATIENT HAD SEVERE OCCLUSIVE DISEASE WITH MULTIPLE NECROTIC TOES, OPEN WOUNDS ON BILATERAL EXTREMITIES AND GANGRENE PRIOR TO UNDERGOING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY STENTING. THIS LIKELY CONTRIBUTED TO THE REPORTED EVENT. PROCEDURE RELATED HARMS FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FINAL PATIENT STATUS WAS NOT REPORTED. 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: HEALTH EFFECT - CLINICAL CODE ¿ REMOVE 4580 H6: HEALTH EFFECT - IMPACT CODE ¿ ADD 4626 AMPUTATION H6: MEDICAL DEVICE PROBLEM CODE ¿ REMOVE 3190 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 ON (B)(6) 2024. FOUR DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFTS WERE IMPLANTED. THE PATIENT WAS REPORTED TO BE FINE POST-IMPLANT. THE LAST WEEKEND OF JANUARY, THE PATIENT PRESENTED WITH COLD LEG. ON (B)(6) 2024, THE PATIENT'S LEG WAS AMPUTATED. THERE ARE CURRENTLY NO DETAILS AVAILABLE REGARDING THE REASON FOR THE AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114983 DETOUR SYSTEM TORUS PERIPHERAL STENT GRAFT QWM ENDOLOGIX MILPITAS TSG-6.7X100 M027212

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Disability TORUS PERIPHERAL STENT GRAFT (LN M0145-22)| TORUS PERIPHERAL STENT GRAFT (LN M0181-30)| TORUS PERIPHERAL STENT GRAFT (LN M0371-07)