BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTEGRAFT

    MDR report key: 23257709 · Received October 9, 2025

    Report

    Report Number
    2247686-2025-00015
    Event Type
    Death
    Date Received
    October 9, 2025
    Date of Event
    September 15, 2025
    Report Date
    September 29, 2025
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GRAFT WAS NOT RECEIVED FOR EVALUATION AFTER BEING IMPLANTED. UPON FURTHER REVIEW, ALTHOUGH A POSSIBLE ROOT CAUSE IS MOST LIKELY DUE TO INFECTION, THE OPERATING SURGEON STATED THAT THE CAUSE OF DEATH IS CVA AND ASPIRATION PNEUMONIA. THE LEMAITRE CLINICAL ADVISOR DOES NOT BELIEVE THAT THE ISSUE WAS CAUSED BY THE ARTEGRAFT COLLAGEN VASCULAR GRAFT. THE CLINICAL ADVISOR'S STATEMENT IS AS FOLLOWS: THE INFECTION AND SUBSEQUENT GRAFT FAILURE WERE ATTRIBUTED TO THE PATIENT'S HISTORY OF MULTIPLE FEMORAL INTERVENTIONS AND HIGH-RISK CLINICAL FACTORS, INCLUDING RENAL DISEASE, DIABETES MELLITUS, OBESITY, MALNUTRITION, SMOKING, AND THE NATURE OF REVISION SURGERY. PROCEDURAL RISKS SUCH AS REDO-GROIN OPERATIONS, LYMPHATIC DISRUPTION, HEMATOMA FORMATION, AND PRESENCE OF FOREIGN BODIES FURTHER INCREASED SUSCEPTIBILITY TO INFECTION. A REVIEW OF THE DEVICE BATCH HISTORY RECORD WAS COMPLETED. PRODUCT BATCH 25B052 MET THE REQUIREMENTS FOR ALL IN-PROCESS TESTING (INCLUDING PRESSURE TESTING AND STERILITY) AND FINAL VISUAL INSPECTION PER PS 001, PROCESSING THE ARTEGRAFT. NO ISSUES WERE NOTED THAT COULD BE RELATED TO THIS ISSUE. A REVIEW OF COMPLAINTS WAS COMPLETED AND THERE WERE NO ADDITIONAL COMPLAINTS WERE REPORTED FOR 25B052 OR ANY ISSUES NOTED. BASED ON THE DOCUMENTATION AND COMPLAINT HISTORY REVIEW, WE DO NOT BELIEVE THERE IS A SYSTEMIC ISSUE WITH THESE DEVICES. NO FURTHER ACTIONS WERE DETERMINED TO BE NECESSARY AT THIS TIME; ALL PRODUCT QUALITY AND CLINICAL ISSUES WILL CONTINUE TO BE MONITORED WITH QUALITY ASSURANCE TRENDING. NO RELATED NCMR/CAPA WAS IDENTIFIED. LEMAITRE CURRENT RISK CONTROLS WERE DETERMINED TO BE SUFFICIENT AT THIS TIME.

    Description of Event or Problem · 0

    PHYSICIAN NARRATIVE: THE PATIENT WAS PRESENTED WITH A MYCOTIC BLOW-OUT FROM A CROSSOVER BYPASS, 5 WEEKS AND 4 DAYS AFTER THE INITIAL SURGERY. DURING EXPLORATION OF THE GROIN, WE FOUND PUS AROUND THE GRAFT WITH DEHISCENCE FROM THE ARTERY, AND WHEN MANIPULATING THE GRAFT IT COMPLETELY DISINTEGRATED. THE PATIENT REPORTED BLEEDING FROM THE GROIN THAT HAD STARTED FIVE DAYS EARLIER. THE PRECISE CAUSE WASN'T ESTABLISHED, BUT THE DELAY IN SEEKING CARE MAY HAVE CONTRIBUTED TO AN UNDIAGNOSED SURGICAL SITE INFECTION, EVENTUALLY CAUSING THE BLEED. THE PATIENT HAD ALSO STOPPED TAKING PRESCRIBED ANTICOAGULANTS (LOW-DOSE RIVAROXABAN AND CLOPIDOGREL) DURING THIS PERIOD. THE PATIENT SUFFERED AN ISCHEMIC STROKE THE DAY AFTER THE SALVAGE SURGERY, WHICH WAS COMPLICATED BY ASPIRATION PNEUMONIA, RESPIRATORY FAILURE, AND THEN HEMODYNAMIC INSTABILITY REQUIRING ICU CARE. AFTER DISCUSSING THE CASE WITH VARIOUS SPECIALTIES, IT WAS DECIDED TO STOP FURTHER INTERVENTION DUE TO POOR PROGNOSIS, AND THE PATIENT PASSED AWAY SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2046033 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC. AG730M 25B052

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention| D| H