BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXICOR

    MDR report key: 23386361 · Received October 24, 2025

    Report

    Report Number
    3005619880-2025-00011
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    March 24, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ELUTIA INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE IS AVAILABLE FOR EVALUATION. LHR REVIEW IS UNABLE TO BE COMPLETED AS THE PRODUCT INFORMATION (MODEL NUMBER AND LOT NUMBER) IS UNKNOWN. IT IS NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20706 REV. B, IFU, PROXICOR FOR CARDIAC TISSUE REPAIR) PROVIDED WITH THE FINISHED PROXICOR FOR CTR DEVICE, THAT PSEUDOANEURYSM AND ANEURYSM ARE LISTED WITHIN THE POTENTIAL COMPLICATIONS ASSOCIATED WITH DEVICE USAGE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME, SHOULD ELUTIA RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, PUBLICATION TITLED "RAPID ANEURYSMAL DEGENERATION OF CORMATRIX PATCH FOLLOWING COARCTATION REPAIR" (CHANCE BENNER, DO AND MARCUS HAW, MD) WAS SENT TO ELUTIA ON MAY 7, 2025. THE ARTICLE DISCUSSES A CASE REPORT WHERE A "CORMATRIX PATCH" WAS USED IN SURGICAL PROCEDURE FOR AORTIC COARCTATION REPAIR. THE ARTICLE DESCRIBES THE PATIENT AS A 4 YEAR OLD MALE WHO, AFTER 1.5 YEARS POST-IMPLANT, PRESENTED ASYMPTOMATIC, HOWEVER ECHOCARDIOGRAM INDICATED RAPID DILATION OF THE AORTIC ARCH, AND A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM REVEALED A 4.4-CM ANEURYSM OF THE AORTIC ARCH WITH TWO PSEUDOANEURYSMS. THE PATIENT WAS WEANED FROM BYPASS WITHOUT SUPPORT AND TRANSITION TO THE INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT COMPLICATION ON POSTOPERATIVE DAY 4. POSTOPERATIVE ECHOCARDIOGRAM SHOWED A WIDELY PATENT AORTIC ARCH AND NORMAL CARDIAC FUNCTION. THE EXPLANTED PATCH MEASURED 4.2 X 3 CM AND WAS THICKENED BUT WITHOUT CALCIFICATION. HISTOLOGIC EXAMINATION SHOWED ENDOTHELIALIZATION WITH NO CALCIFICATION. PER THE ARTICLE, THE EXACT REASON WHY THE PATIENT'S RECONSTRUCTION FAILED IS UNKOWN. THE PHYSICIAN HYPOTHESIZED THE HIGH-PRESSURE ENVIRONMENT DEGENERATED THE PATCH AT AN ACCELERATED RATE AND THAT THE ECM PATCH MATERIAL FAILED TO REGENERATE INTO A ROBUST TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577274 PROXICOR PATCH, PLEDGET-INTRACARDIAC-DXZ, PRODUCT CODE: DXZ DXZ ELUTIA INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention