BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCURE FOR VASCULAR REPAIR

    MDR report key: 21163855 · Received January 15, 2025

    Report

    Report Number
    3005619880-2025-00002
    Event Type
    Injury
    Date Received
    January 15, 2025
    Date of Event
    November 4, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ELUTIA INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE IS AVAILABLE FOR EVALUATION. MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE DETAILED INFORMATION FROM DR. (B)(6) WITH NO RESPONSE TO DATE. IT WAS NOTED THAT THE ORIGINAL DATE, ((B)(6) 2024), THE INCIDENT WAS PROCESSED THROUGH A "HEALTHTRUST" PORTAL PRIOR TO NOTIFICATION TO ELUTIA, IS BEING USED AS THE DATE OF EVENT, AS THE ACTUAL DATE OF THE EVENT WAS NOT ABLE TO BE CONFIRMED. MANUFACTURING REVIEW OF THE VASCURE FOR VASCULAR REPAIR DEVICE HISTORY RECORD WAS COMPLETED RESULTING IN NO QUALITY ISSUES IDENTIFIED DURING PROCESSING OF THE LOT. ADDITIONALLY, THE SUBCONTRACTOR WAS ASKED TO PERFORM AN EVALUTION OF THE MANUFACTURING BATCH RECORDS FOR TISSUE PROCESSING LOTS USED IN ELUTIA'S MANUFACTURING LOT, RESULTING IN NO QUALITY ISSUES IDENTIFIED DURING THEIR MANUFACTURING PROCESS. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20708 REV. A, IFU VASCURE FOR VASCULAR REPAIR) PROVIDED WITH THE FINISHED VASCURE FOR VASCULAR REPAIR DEVICE, THAT AN ANEURYSM IS IDENTIFIED IN THE INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH CAROTID ARTERY / VASCULAR SURGICAL PROCEDURES AND DEVICE USAGE.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED FROM ELUTIA'S BUSINESS PARTNER ON 17-DECEMBER-2024 OF TWO (2) ADVERSE EVENTS RELATED TO PATIENTS HAVING BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR PATCH (1CM X 10CM) DEVELOPING ANEURYSMS AFTER IMPLANT. THE REPORTED EVENTS WILL BE FILED IN 2 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND REPORTED ELUTIA PRODUCT INFORMATION. A 1CM X 10CM SIZE VASCURE FOR VASCULAR REPAIR PATCH (MODEL # CMCV-013-609, LOT M24D1113) WAS USED TO TREAT PATIENT #2 AND IS THE SUBJECT OF THIS REPORT. THE SECOND EVENT (PATIENT #2) WILL BE ADDRESSED IN. 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
    2088776 VASCURE FOR VASCULAR REPAIR PATCH, PLEDGET-INTRACARDIAC-DXZ DXZ ELUTIA INC. CMCV-013-609 M24D1113 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention