BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROXICOR FOR CARDIAC TISSUE REPAIR

    MDR report key: 10665296 · Received October 12, 2020

    Report

    Report Number
    3005619880-2020-00047
    Event Type
    Death
    Date Received
    October 12, 2020
    Report Date
    October 12, 2020
    Manufacturer
    AZIYO BIOLOGICS INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE PROXICOR FOR CARDIAC TISSUE REPAIR DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT/SERIAL NUMBER IS UNKNOWN. IT IS ALSO NOTED THAT PER THE INSTRUCTIONS FOR USE (IFU - ART-20700B) PROVIDED WITH THE FINISHED PROXICOR FOR CARDIAC TISSUE REPAIR DEVICE, INFECTION AND STENOSIS ARE LISTED AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PROCEDURE AND DEVICE. ALTHOUGH THE EXACT CAUSE OF THE REPORTED INFECTION AND STENOSIS CANNOT BE CONCLUSIVELY DETERMINED, INFECTION, STENOSIS ARE A KNOWN COMPLICATIONS ASSOCIATED WITH THE USE OF A PROXICOR FOR CARDIAC TISSUE REPAIR AND A SURGICAL IMPLANT PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME, SHOULD AZIYO RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED. PROXICOR FOR CARDIAC TISSUE REPAIR 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.

    Description of Event or Problem · 1

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, THIS ARTICLE / CLINICAL CASE REPORT PUBLISHED IN CARDIOVASCULAR PATHOLOGY 25 (2016) PP165-168 TITLED "NOVEL VALVE REPLACEMENT WITH EXTRACELLULAR MATRIX SCAFFOLD IN AN INFANT WITH SINGLE VENTRICLE PHYSIOLOGY" WAS REVIEWED. THIS ARTICLE REPORTS A CASE STUDY RELATED TO A "1 YEAR FOLLOW-UP WITH A CORMATRIX TUBE IMPLANTED AS SYSTEM AVV IN AN INFANT WITH FUNCTIONALLY UNIVENTRICULAR HEART (FUVH)." THE ARTICLE REPORTS THAT FOLLOWING MULTIPLE PROCEDURES AT BIRTH AND 86 DAYS WHERE INFANT UNDERWENT PULMONARY BANDING AND SYSTEMIC ATRIO-VENTRICULAR VALVE (AVV) PLASTY AT 86 DAYS, PATIENT DEVELOPED RESIDUAL AVV REGURGITATION CAUSING CONGESTIVE HEART FAILURE AND MECHANICAL VENTILATION DEPENDENCY. AT AGE (B)(6) DAYS, PATIENT UNDERWENT AN AVV REPLACEMENT WITH A HAND-MADE CORMATRIX (NOW AZIYO BIOLOGICS) TUBE (MODEL #: UNKNOWN, LOT #: UNKNOWN - LIKELY PROXICOR FOR CARDIAC TISSUE REPAIR) WHICH DEMONSTRATED WIDE OPENING LEAFLETS, NO REGURGITATION, AND NO VENTRICULAR OUTFLOW TRACT OBSTRUCTION. POST-OPERATIVELY PATIENT EXPERIENCED MULTIPLE FAILED EXTUBATIONS AND TRACHEOSTOMY AT 3 MONTHS POST OP. PROLONGED ANTIBIOTIC IV THERAPY REQUIRED DUE TO POSITIVE BLOOD CULTURES FOR MULTI-DRUG RESISTANT PSEUDOMONAS AERUGINOSA, CANDIDA ALBICANS, AND ENTEROBACTER CLOACAE. FOLLOW-UPS AT 3 MONTHS AND 7 MONTHS DEMONSTRATED EXCELLENT CORMATRIX TUBE FUNCTION. AT AGE (B)(6) MONTHS, DURING ELECTIVE CLINICAL AND HEMODYNAMIC EVALUATION, AN ECHOCARDIOGRAPHY EXAM DEMONSTRATED SEVERE RIGHT ATRIUM DILATION, NO AVV REGURGITATION, BUT A THICKENED CORMATRIX TISSUE, WITH AVV STENOSIS. DUE TO INFECTION AND PROGRESSING HEMODYNAMIC IMPAIRMENT, INOTROPIC SUPPORT AND ANTIBIOTIC THERAPY WAS STARTED. PATIENT UNDERWENT UNEVENTFUL SURGERY CONSISTING OF BIDIRECTIONAL CAVO-PULMONARY SHUNT AND INTRAOPERATIVE DILATION OF THE CORMATRIX TUBE. PATIENT TRANSFERRED TO INTERMEDIATE CARE BEFORE DISCHARGE, BUT DUE TO SEPSIS UNRESPONSIVENESS TO ANTIBIOTIC THERAPY, HE DIED ON POSTOPERATIVE DAY (B)(6). 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
    1128885 PROXICOR FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET, AND INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS INC. CMCV-120-401

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Death| H| R