BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEGRAFT

    MDR report key: 19895118 · Received August 2, 2024

    Report

    Report Number
    2247686-2024-00012
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PATIENTS WERE REPORTED WITH INFECTIONS. THIS REPORT CAPTURES PATIENT 2 OF 2. THE ISSUE WAS NOT ABLE TO BE CONFIRMED. NO PRODUCT WAS RECEIVED FOR EVALUATION. PATIENT INFORMATION INCLUDING STATUS, LOT NUMBERS USED, AND IMPLANTATION DATES WERE REQUESTED, BUT INFORMATION WAS NOT PROVIDED. A REVIEW OF ALL LOT RECORDS RELATED TO GRAFTS SOLD TO THE HOSPITAL BETWEEN JANUARY 2024 AND JULY 2024 WAS COMPLETED AND THERE WERE NO INDICATIONS OR TRENDS IDENTIFIED THAT WOULD SUGGEST AN INCREASE IN INFECTION RATE. NO DEVIATIONS WERE FOUND WITHIN THOSE SPECIFIC LOTS THAT WOULD BE RELATED TO THIS TYPE OF REPORT. NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO THE ISSUE. WITHOUT ADDITIONAL INFORMATION A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE IS LIKELY THAT THE GRAFT WAS IMPLANTED INTO AN INFECTED FIELD OR THE SURGICAL SITE BECAME INFECTED DUE TO WOUND COMPLICATIONS STEMMING FROM THE NATURE OF THE IMPLANT LOCATION. I.E. IT IS COMMON KNOWLEDGE THAT GROIN IMPLANTS ARE HIGHLY SUSCEPTIBLE TO INFECTION IN UP TO 8.1% OF VASCULAR INTERVENTIONS.1 1. GWILYM BL, LOCKER DT, MATTHEWS EK, MAZUMDAR E, ADAMSON G, WALL ML, BOSANQUET DC. SYSTEMATIC REVIEW OF GROIN WOUND SURGICAL SITE INFECTION INCIDENCE AFTER ARTERIAL INTERVENTION. INT WOUND J. 2023 APR;20(4):1276-1291. DOI: 10.1111/IWJ.13959. EPUB 2022 OCT 2. PMID: 36184849; PMCID: PMC10031242. 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 WITHIN QUALITY ASSURANCE TRENDING.

    Description of Event or Problem · 0

    THE PATIENT RECEIVED THE GRAFT APPROXIMATELY 3 WEEKS AGO. GRAFT PLACEMENT IN THE GROIN. THE PATIENT DEVELOPED AN INFECTION PRIOR TO ANY GRAFT ACCESS ATTEMPTS. THE PATIENT WAS SEEN ABOUT 2 WEEKS AGO TO HAVE THE WOUND EVACUATED AND TREATED. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375833 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention