BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 6609836 · Received June 2, 2017

    Report

    Report Number
    3005619880-2017-00019
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    May 2, 2017
    Report Date
    June 2, 2017
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE THAT WAS RETURNED AND USED BY THE FACILITY WAS OBSERVED TO HAVE BEEN SEPARATED ON ONE END OF THE 1 CM X 10 CM STRIP THAT HAD BEEN TRIMMED DURING THE PROCEDURE TO FORM A POINT. APPROXIMATELY 1 CM ON EACH LONG SIDE OF THE ECM STRIP WAS TRIMMED INTO A TRIANGULAR SHAPE, AND IT APPEARED TO BE ONE LAYER OF ECM HAD SEPARATED ON THE APPROXIMATELY 4 CM DEEP INTO THE SAMPLE. NO OTHER AREAS OF SEPARATION WERE OBSERVED. HYDRATION TIMES OF THE RETURNED SAMPLE AS WELL AS HANDLING OF THE ECM PRIOR TO ATTEMPTING IMPLANT IS UNKNOWN. THEREFORE, THE EXACT ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. A LOT SAMPLE OF THE SAME MANUFACTURING LOT PROVIDED BY THE CUSTOMER WAS EVALUATED PER IFU STEPS USING THE MAXIMUM HYDRATION SOAK OF 2 MINUTES, THE ISSUE OF DELAMINATION/SEPARATION OF LAYERS WAS NOT ABLE TO BE CONFIRMED. NO DELAMINATION WAS ABLE TO BE REPRODUCED IN THE LOT SAMPLE PROVIDED WHEN USED PER THE IFU. QUALITY REVIEW OF THE OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED HAVING MET ALL INTERNAL MANUFACTURING SPECIFICATIONS AND QC ACCEPTANCE REQUIREMENTS FOR WORKMANSHIP AND BIOLOGICAL TESTING FOR PRODUCT STERILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PHYSICIAN WAS PLACING THE CORMATRIX ECM FOR VASCULAR REPAIR PRODUCT OVER THE DEFECT AND STARTED SEWING IT IN PLACE. WHILE SUTURING IN PLACE, THE PHYSICIAN NOTICED THAT THE PRODUCT LAYERS HAD STARTED SEPARATING. PHYSICIAN STOPPED, REMOVED THE PRODUCT AND REPLACED IT WITH A DIFFERENT BRAND PRODUCT. THE MODEL AND LOT NUMBER USED ARE CMCV-014-609/ M16F1149. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389032 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-014-609 M16F1149 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention