BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYKE

    MDR report key: 10955931 · Received December 6, 2020

    Report

    Report Number
    3005619880-2020-00106
    Event Type
    Injury
    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 STENOSIS AND 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 PATIENT #8 AS REFERENCED IN TABLE 1: SUMMARY TABLE OF THE EIGHT PATIENTS WHO INITIALLY UNDERWENT MITRAL VALVE REPAIR HOWEVER UNDER DIRECT INSPECTION, THE SURGEON DETERMINED REPAIR WAS NOT FEASIBLE AND MITRAL VALVE REPLACEMENT WAS PERFORMED. PATIENT #8 WAS IDENTIFIED WITH CONGENITAL MITRAL ARCADE/STENOSIS UNDERWENT ECM-MV REPLACEMENT AT THE AGE OF 5.8 MONTHS WITH CONCURRENT ASD CREATION DURING THE PROCEDURE. THIS PATIENT IS CURRENTLY 31 MONTHS POST-OP, AND CURRENTLY HAS TRIVIAL STENOSIS AND REGURGITATION. THE CORMATRIX EMC-MV REMAINS IMPLANTED AND FUNCTIONAL. 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
    1421028 TYKE PATCH, PLEDGET, INTRACARDIAC - DXZ DXZ AZIYO BIOLOGICS, INC. CMCV-098-204 00859389005102

    Patients

    Seq Age Sex Outcome Treatment
    1 5.8 MO Other