BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE

    MDR report key: 22878007 · Received August 22, 2025

    Report

    Report Number
    3005619880-2025-00008
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 22, 2025
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    UDI-DI
    00859389005348
    PMA / PMN Number
    K233991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ELUTIA LHR REVIEW COMPLETED ON 08/19/2025 FOR LOT M25C1060 AND SUBASSEMBLY LOT M25B1038. NO DISCREPANCIES IN THE MANUFACTURING PROCESS WERE NOTED IN EITHER BATCH RECORD DURING REVIEW. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART20837 REV. A, IFU ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE) PROVIDED WITH THE FINISHED ELUPRO DEVICE, "INFECTION" IS LISTED WITHIN THE POTENTIAL COMPLICATIONS ASSOCIATED WITH DEVICE USAGE. INFECTION IS A KNOWN COMPLICATION WITH THE IMPLANT OF A CARDIAC IMPLANTABLE DEVICE FOR CARDIAC SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    EMAIL WAS RECEIVED FROM AN ELUTIA SALES REPRESENTATIVE REGARDING A PATIENT ADVERSE EVENT. IT WAS REPORTED THAT, THE PATIENT HAD A POCKET REVISION WITH A BIVICD WITH AV NODE PACEMAKER IMPLANT ON (B)(6) 2026 ALONG WITH THE IMPLANT OF A LARGE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL CMCV-124-LRG, LOT M25C1060). AT DEVICE CHECK, THE SITE BECAME AWARE THAT THE PATIENT DEVELOPED RED OOZING AND WAS TREATED WITH ORAL ANTIBIOTICS. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH BROWN LIQUID OOZING; IV ANTIBIOTICS WERE GIVEN. ON (B)(6) 2025 THE DEVICE WAS EXPLANTED. ANOTHER DEVICE WAS RE-IMPLANTED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667712 ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE CANGAROO RM ANTIBACTERIAL ENVELOPE FTM ELUTIA INC. CMCV-124-LRG M25C1060 00859389005348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H