BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE

    MDR report key: 24824269 · Received April 8, 2026

    Report

    Report Number
    3005619880-2026-50003
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    August 29, 2025
    Report Date
    April 8, 2026
    Manufacturer
    ELUTIA INC.
    Product Code
    FTM
    UDI-DI
    00859389005348
    PMA / PMN Number
    K233991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW OF THE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE DEVICE HISTORY RECORD WAS COMPLETED ON 08APR2026 AND IDENTIFIED NO QUALITY ISSUES OR NONCONFORMANCES DURING PROCESSING OF THE FINAL PACKAGED LOT OR STERILE SUBASSEMBLY LOT. ALL DRUG PERFORMANCE TESTING MET ESTABLISHED QA RELEASE CRITERIA FOR ASSAY, ELUTION PROFILE, IMPURITIES AND ENDOTOXIN TESTING. IT IS NOTED THAT THE INSTRUCTIONS FOR USE (IFU - ART20837 REV. A) PROVIDED WITH EACH ELUPRO BIOENVELOPE DEVICE LISTS INFLAMMATION AND INFECTION AS POTENTIAL COMPLICATIONS ASSOCIATED WITH DEVICE USAGE AND A CIED IMPLANTATION PROCEDURE. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE REGISTRY POST MARKET CLINICAL STUDY THAT A 71 YR. OLD MALE PATIENT (SUBJ. (B)(6) UNDERWENT A BATTERY/GENERATOR CHANGE-OUT PROCEDURE ON (B)(6) 2025 USING AN ELUPRO BIOENVELOPE (MODEL # CMCV-124-LRG; LOT #M25B1030). A COMBINATION OF SALINE AND IRRISEPT WERE UTILIZED TO REHYDRATE THE ELUPRO DEVICE FOR 5 SECONDS. NO CONCERNS OR COMPLAINTS WERE REPORTED DURING OR AFTER THE IMPLANTATION WAS COMPLETE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT OF POSSIBLE CELLULITIS, WITH NO POCKET INFECTION OBSERVED. THE PATIENT WAS PRESCRIBED 100MG DOXYCYCLINE. THE ADVERSE EVENT WAS SUSPECTED TO BE POSSIBLY RELATED TO BOTH THE CIED PROCEDURE AND THE ELUPRO BIOENVELOPE DEVICE. AT SUBSEQUENT PATIENT FOLLOW-UP, THE REPORTED CELLULITIS HAD RESOLVED WITHOUT SEQUELAE, NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT, SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873512 ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE CANGAROO RM ANTIBACTERIAL ENVELOPE FTM ELUTIA INC. CMCV-124-LRG M25B1030 00859389005348

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other