BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE

    MDR report key: 23804237 · Received December 15, 2025

    Report

    Report Number
    3005619880-2025-50011
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    July 25, 2025
    Report Date
    April 8, 2026
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    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 - ART-20837 REV. A, IFU ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE) PROVIDED WITH THE FINISHED ELUPRO DEVICE, "INFECTION" AND "HEMATOMA" ARE LISTED WITHIN THE POTENTIAL COMPLICATIONS ASSOCIATED WITH DEVICE USAGE. INFECTION AND HEMATOMA ARE KNOWN COMPLICATIONS WITH THE IMPLANT OF A CARDIAC IMPLANTABLE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2025 A SALES REPRESENTATIVE NOTIFIED BOSTON SCIENTIFIC THAT A PATIENT WHO UNDERWENT A VALVE REPLACEMENT SURGERY WITH DR. (B)(6) AT (B)(6) EXPERIENCED A HEMATOMA WHICH LEAD TO AN INFECTION. THE PATIENT WAS IMPLANTED WITH AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE DEVICE (MODEL NUMBER AND LOT NUMBER ARE UNKNOWN); DATE OF IMPLANT IS UNKNOWN. THE PATIENT WAS ON WARFARIN. NO FURTHER INFORMATION REGARDING THIS EVENT WAS PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN WITH NO FURTHER INFORMATION HAVING BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766403 ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE CANGAROO RM ANTIBACTERIAL ENVELOPE FTM ELUTIA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other