BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE

    MDR report key: 22777214 · Received August 11, 2025

    Report

    Report Number
    3005619880-2025-00007
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    June 6, 2025
    Report Date
    August 11, 2025
    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

    ELUTIA LHR REVIEW COMPLETED ON 08/08/2025 FOR LOT M25A1005 AND SUBASSEMBLY LOT M24N1343. 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, "HEMATOMA" IS LISTED WITHIN THE POTENTIAL COMPLICATIONS ASSOCIATED WITH DEVICE USAGE. HEMATOMA 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 THE ELUTIA REPRESENTATIVE REGARDING A PATIENT IN AN ELUTIA REGISTRY STUDY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT HAD A POCKET REVISION WITH A PACEMAKER IMPLANT ALONG WITH THE IMPLANT OF A LARGE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL CMCV-124-LRG, LOT M25A1005). ON 06/10/2025, THE SITE BECAME AWARE (PATIENT ONSET (B)(6) 2025) THAT THE PATIENT DEVELOPED A HEMATOMA AND WAS TREATED WITH ORAL ANTIBIOTICS (DOXYCYCLINE) AND RIVAROXABAN (HELD 3 DAYS). AFTER (B)(6) 2025, THE PATIENT DID NOT NOTE ANY SYMPTOMS RELATED TO A HEMATOMA. THE SITE ALSO NOTED THAT THE PATIENT DID NOT HAVE ANY EXISTING CONDITIONS OR COMORBIDITIES WHICH COULD HAVE CONTRIBUTED TO THE HEMATOMA. NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS EVENT BUT IF ELUTIA RECEIVES MORE INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160461 ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE CANGAROO RM ANTIBACTERIAL ENVELOPE FTM ELUTIA INC. CMCV-124-LRG M25A1005 00859389005348

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention