BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE

    MDR report key: 22911269 · Received August 28, 2025

    Report

    Report Number
    3005619880-2025-00009
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    March 5, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    UDI-DI
    00859389005331
    PMA / PMN Number
    K233991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 CRTD BIV PACEMAKER IMPLANT ON (B)(6) 2025 ALONG WITH THE IMPLANT OF A MEDIUM ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL - CMCV-124-MED, LOT NUMBER - UNKNOWN). THE SALES REPRESENTATIVE NOTED THAT THE PATIENT HAD AN INFECTION ON (B)(6) 2025. THE DEVICE WAS REMOVED ON (B)(6) 2025 AND A NEW DEVICE WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PHYSICIAN CONFIRMED THAT THE ELUPRO DEVICE WAS NOT THE CAUSE OF THE INFECTION. NO FURTHER INFORMATION REGARDING THIS EVENT IWAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834101 ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE CANGAROO RM ANTIBACTERIAL ENVELOPE FTM ELUTIA INC. CMCV-124-MED 00859389005331

    Patients

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