BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 5114544 · Received September 30, 2015

    Report

    Report Number
    3005619880-2015-00046
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 2, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    UDI-DI
    00859389005140
    PMA / PMN Number
    K140789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECM TISSUE SAMPLE WAS NOT RETURNED TO CORMATRIX FOR EVALUATION. MANUFACTURING RECORDS FOR LOT M15G1170 HAVE BEEN REVIEWED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE ONLY EVENT ASSOCIATED WITH LOT M15G1170 TO DATE. THE PRODUCT IFU STATES UNDER WARNINGS AND PRECAUTIONS, "EXCESSIVE HYDRATION MAY RESULT IN DELAMINATION. IF DELAMINATION IS OBSERVED, DO NOT USE THE CORMATRIX ECM." UNDER THE INSTRUCTIONS FOR USE, "HYDRATE THE CORMATRIX ECM BY PLACING IT IN A BOWL OF STERILE SALINE OR OTHER STERILE ISOTONIC SOLUTION FOR APPROXIMATELY 1-2 MINUTES PRIOR TO USE... IT IS RECOMMENDED THAT THE ECM NOT BE EXCESSIVELY HANDLED OR MANIPULATED PRIOR TO USE... IF DELAMINATION IS OBSERVED, DO NOT IMPLANT THE CORMATRIX ECM."

    Description of Event or Problem · 1

    ON (B)(4) 2015, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR VASCULAR REPAIR AND A REPORTED CASE OF DELAMINATION. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT DURING A CASE INVOLVING A MALE PATIENT, IN HIS 60'S, A 1X10 ECM MODEL # CMCV-013-609, LOT # M15G1170 WAS OBSERVED TO DELAMINATE, AND PEEL BACK UPON APPROXIMATELY 35 SECONDS OF HYDRATION IN SALINE SOLUTION. NO REPORT OF PROCEDURAL DELAY AND NO PATIENT IMPACT AS THE PRODUCT WAS DISCARDED AND A NEW PRODUCT FROM THE SAME LOT WAS USED WITH NO OBSERVED INCIDENT. SAMPLE WAS THROWN OUT AND WILL NOT BE RETURNED. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644063 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-013-609 M15G1170 00859389005140

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR