BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 8287868 · Received January 29, 2019

    Report

    Report Number
    3005619880-2019-00003
    Event Type
    Injury
    Date Received
    January 29, 2019
    Report Date
    January 29, 2019
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR EVALUATION. THE MODEL NUMBER AND LOT NUMBER ARE NOT ABLE TO BE OBTAINED. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE CORRESPONDENCE AUTHOR (DR. JAGDISH BUTANY) WERE MADE WITHOUT SUCCESS (12/30/18, 1/3/19, 1/11/19, 1/18/19). ALTHOUGH THE EXACT PRODUCT INFORMATION IS NOT AVAILABLE, THE REPAIR WAS LIKELY PERFORMED USING THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR, WHICH IS INDICATED FOR USE AS AN INTRACARDIAC PATCH OR PLEDGET FOR TISSUE REPAIR (I.E., ATRIAL SEPTAL DEFECT (ASD), VENTRICULAR SEPTAL DEFECT (VSD), ETC.) AND SUTURE-LINE BUTTRESSING. PER THE IFU THAT WAS PROBABLY PACKAGED WITH THE LOT BASED ON PRESUMED IMPLANT DATES (PART #20123-080812) IT STATES UNDER "POTENTIAL COMPLICATIONS: PATCH DEHISCENCE, REFORMATION OF INTRACARDIAC DEFECT." IT IS UNKNOWN IF THE REPORTED COMPLICATION MAY ALSO BE RELATED TO PATIENT CO-MORBIDITIES, THE SURGICAL PROCEDURE, OTHER DEVICES, OR TREATMENTS. THE ARTICLE MAKES MENTION THAT THERE WAS "MINIMAL INTEGRATION OF HOST TISSUE CELLS AND PRESERVATION OF THE MATERIAL ITSELF AND DID NOT SHOW REABSORPTION. IT IS POSSIBLE THAT THE LACK OF REABSORPTION MAY BE RELATED TO THE VARYING HEMODYNAMIC LOADS OF THE RIGHT AND LEFT SIDE OF THE HEART, AS WELL AS THE VARYING HOST RESPONSE BETWEEN THE PEDIATRIC AND ADULT POPULATION. THE PRESENCES OF ACTIVE ENDOCARDITIS MAY ALSO ALTER THE NORMAL REMODELING PROPERTIES OF THE CORMATRIX. EXPLANTED TISSUES OF LONGER DURATION ARE NEEDED TO "ASCERTAIN" IF THERE IS INTEGRATION OF LOCAL AND HOST CELLS INTO THE CORMATRIX MATERIAL." (LUK, 2015). THE EXACT ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    PER ARTICLE "CORMATRIX EXTRACELLULAR MATRIX USED FOR VALVE REPAIR IN THE ADULT: IS THERE DE NOVO VALVULAR TISSUE SEEN?" (PATIENT 2). A (B)(6)-YEAR-OLD MAN WAS IN HEART FAILURE AND BLOOD CULTURES WERE POSITIVE FOR ENTEROCOCCUS FAECALIS. HE HAD SEVERE AORTIC INSUFFICIENCY AND MITRAL REGURGITATION (MR) WITH VEGETATIONS ON BOTH VALVES. PERFORATION WAS SEEN IN THE ANTERIOR MITRAL VALVE LEAFLET (AMVL). HE UNDERWENT AORTIC VALVE REPLACEMENT WITH A HANCOCK II #25 BIOPROSTHESIS AND MITRAL VALVE REPAIR, WITH PARTIAL RESECTION OF THE BODY OF THE ANTERIOR MITRAL VALVE LEAFLET AND REPAIR WITH A CORMATRIX PATCH (SIZE UNKNOWN). EIGHTEEN MONTHS LATER HE PRESENTED WITH A PERFORATION OF THE AMVL, AMONG OTHER COMPLICATIONS. BASED ON REASONABLE DEDUCTION OF THE APPLICATION BEING USED, IT WAS CONCLUDED THAT THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PRODUCT WAS UTILIZED. BASED ON THE ARTICLE BEING PUBLISHED ON AUGUST 29, 2014 AND TWO PATIENTS REFERENCED WITHIN THE ARTICLE THAT HAD IMPLANTS FOR APPROXIMATELY 10 MONTHS AND 18 MONTHS RESPECTIVELY, IT CAN BE REASONABLY PRESUMED THAT THE SURGERY DATES WERE AROUND EARLY 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79104 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ AZIYO BIOLOGICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention