BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 4905130 · Received July 8, 2015

    Report

    Report Number
    3005619880-2015-00035
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 10, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K140789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE DELAMINATION IS UNKNOWN. THE ECM TISSUE SAMPLE WAS NOT RETURNED TO CORMATRIX FOR EVALUATION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. MANUFACTURING RECORDS FOR LOT M15C1070 HAVE BEEN REVIEWED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES FOUND DURING THE REVIEW. THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT M15C1070 TO DATE.

    Description of Event or Problem · 1

    ON JUNE 10, 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 CAROTID CASE THE PATCH DELAMINATED. SURGEON STATED THAT DELAMINATION WAS OBSERVED THROUGHOUT PRODUCT. THE ECM WAS HYDRATED FOR APPROXIMATELY 2 MINUTES. THE SALES REP. ADVISED THE SURGEON TO NOT USE THE PRODUCT IF DELAMINATION WAS OBSERVED. THE SURGEON INDICATED THAT THE PRODUCT WAS ALREADY SEEN INTO PLACE AND HE WAS NOT PLANNING ON REMOVING THE PATCH. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443441 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET, INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-013-609 M15C1070

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR