BEUDAMED
    FDA Adverse Event Death Summary report: N

    TYKE

    MDR report key: 10955908 · Received December 6, 2020

    Report

    Report Number
    3005619880-2020-00100
    Event Type
    Death
    Date Received
    December 6, 2020
    Report Date
    December 6, 2020
    Manufacturer
    AZIYO BIOLOGICS, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005102
    PMA / PMN Number
    K152127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW OF THE CORMATRIX TYKE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. NO SPECIFIC TREATMENT DATES WERE PROVIDED ASIDE FROM PATIENTS RECORDS SELECTED FOR THIS RETROSPECTIVE REVIEW OCCURRED BETWEEN MAY 2013 AND OCTOBER 2017, HOWEVER, THE TYKE PRODUCT WAS NOT RELEASED FOR DISTRIBUTION UNTIL MAY 2016. INFORMATION CITED IN THE ARTICLE STATES THAT "PATIENTS UNDERWENT A MITRAL VALVE REPLACEMENT USING THE TYKE ECM PATCH TO FORM A CUSTOM-MADE CYLINDER MITRAL VALVE REPLACEMENT". THE INSTRUCTIONS FOR USE (ART-20712A) PROVIDED WITH THE DISTRIBUTED PRODUCT STATES UNDER WARNINGS AND PRECAUTIONS THAT "TYKE IS NOT INDICATED FOR THE CONSTRUCTION OR REPLACEMENT OF TOTAL VALVES OR CONDUITS". ALTHOUGH THE EXACT CAUSE OF THE REPORTED ISSUES CANNOT BE CONCLUSIVELY DETERMINED, THE REPORTED DEATH AND/OR REGURGITATION ARE IDENTIFIED IN THE INSTRUCTIONS FOR USE AS POTENTIAL COMPLICATIONS PROVIDED WITH THE TYKE PRODUCT. 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, SINGLE SURGEON STUDY REPORT PUBLISHED IN PEDIATRIC CARDIOLOGY TITLED "MITRAL VALVE REPLACEMENT IN PEDIATRICS USING AN EXTRACELLULAR MATRIX CYLINDER VALVE: A CASE SERIES" WAS REVIEWED. THIS ARTICLE SUMMARIZES THE RESULTS OF EIGHT (8) CHILDREN UNDER THE AGE OF 2 YEARS WHO UNDERWENT ECM CUSTOM-MADE CYLINDER VALVES FOR MITRAL VALVE REPLACEMENT. THE STUDY STATES THAT THESE PATIENTS WERE TREATED BETWEEN MARCH 2013 AND OCTOBER 2017 USING THE CORMATRIX (NOW AZIYO BIOLOGICS) TYKE 2-PLY EXTRACELLULAR MATRIX MATERIAL (MODEL # / LOT #: UNKNOWN). THIS REPORT IS FOCUSED ON THE PATIENT #2 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR, HOWEVER DUE TO A SEVERE MITRAL VALVE INJURY DURING THE SAME PROCEDURE, AN ECM MITRAL VALVE WAS PLACED. THE ARTICLE STATES THAT THE HOSPITAL COURSE WAS COMPLICATED BY PROLONGED OPEN CHEST, ATRIAL ARRHYTHMIAS, PULMONARY HYPERTENSION. THIS PATIENT UNDERWENT THE INITIAL MITRAL VALVE REPAIR PROCEDURE AT AGE OF APPROXIMATELY 21 DAYS. AT 3 MONTHS POST-OP, THE POST ECM-MVR REPLACEMENT, THIS PATIENT DEVELOPED SEVERE MITRAL VALVE REGURGITATION AND DIED DUE TO PULMONARY HYPERTENSION AND RESPIRATORY INSUFFICIENCY. THE LAST IN-FLOW GRADIENT MEASUREMENTS AT 3 MONTHS POST-OP SHOWED A MEAN INFLOW GRADIENT OF 11 MMHG AND TRIVIAL REGURGITATION. ATTEMPTS TO CONTACT THE CORRESPONDING AUTHOR HAVE BEEN SUCCESSFUL AT THIS TIME, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420944 TYKE PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS, INC. CMCV-098-204 00859389005102

    Patients

    Seq Age Sex Outcome Treatment
    1 0.7 MO Death