BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 10816157 · Received November 10, 2020

    Report

    Report Number
    3005619880-2020-00062
    Event Type
    Injury
    Date Received
    November 10, 2020
    Report Date
    November 10, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT/SERIAL NUMBER WAS NOT PROVIDED. IT IS NOTED THAT THE REPORTED COMPLICATION ASSOCIATED WITH ARRHYTHMIA IS ASSOCIATED WITH THE SURGICAL PROCEDURE AND NOT RELATED TO THE AZIYO DEVICE. ALTHOUGH THE EXACT CAUSE OF THE REPORTED ISSUES CANNOT BE CONCLUSIVELY DETERMINED, ARRHYTHMIA IS A KNOWN COMPLICATION ASSOCIATED WITH THE CAVSD SURGICAL PROCEDURE. SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS RETROSPECTIVE SINGLE CENTER STUDY REPORT PUBLISHED IN THE WORLD JOURNAL OF PEDIATRIC AND CONGENITAL HEART SURGERY TITLED "REPAIR OF COMPLETE ATRIOVENTRICULAR SEPTAL DEFECTS WITH DECELLULARIZED EXTRACELLULAR MATRIX: INITIAL AND MIDTERM OUTCOMES" WAS REVIEWED. THIS ARTICLE PROVIDES THE RESULTS OF FIFTEEN (15) PATIENTS WHO UNDERWENT SURGERY FOR A TWO-PATCH COMPLETE ATRIOVENTRICULAR SEPTAL DEFECT (CAVSD) BETWEEN APRIL 2010 AND JULY 2014 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) EXTRACELLULAR MATRIX MATERIAL. THIS REPORT IS FOCUSED ON PATIENT #3 (PER PUBLICATION TABLE 1: PATIENT DEMOGRAPHICS AND ECHOCARDIOGRAPHIC DATA) FOR A (B)(6) DAY OLD FEMALE WHO UNDERWENT CAVSD REPAIR WITH AN UNSPECIFIED PIECE OF CORMATRIX ECM, LIKELY CORMATRIX ECM FOR CARDIAC TISSUE REPAIR (NOW AZIYO BIOLOGICS MODEL #: UNKNOWN, LOT#: UNKNOWN). AT AN UNKNOWN PERIOD OF TIME POST-OP (MEAN FOLLOW-UP STATED AS 1364 DAYS WITH NO RANGE), THE PATIENT DEVELOPED ARRHYTHMIA WHICH WAS MANAGED MEDICALLY. THE ARTICLE STATES THAT NO PERMANENT PACEMAKERS WERE REQUIRED AND THAT ALL POST-OPERATIVE COMPLICATIONS IN THE STUDY WERE NONPERMANENT AND ONLY REQUIRED MANAGEMENT IN THE IMMEDIATE POSTOPERATIVE PERIOD. ATTEMPTS TO CONTACT CORRESPONDING AUTHOR HAVE BEEN UNSUCCESSFUL FOR ANY ADDITIONAL INFORMATION. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283289 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention