BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 4908365 · Received July 9, 2015

    Report

    Report Number
    3005619880-2015-00036
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K140789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED BY CORMATRIX ON JUNE 17, 2015. HISTOLOGY EVALUATION WAS PERFORMED IN THE ARE IN WHICH DELAMINATION WAS OBSERVED. THE SAMPLE WAS SECTIONED AND STAINED WITH AN H&E AND A MOVAT PENTACHROME STAIN. ALTHOUGH DELAMINATION WAS OBSERVED BOTH MACROSCOPICALLY AND MICROSCOPICALLY, THERE WAS NO DIFFERENCE HISTOLOGICALLY FROM WHAT IS EXPECTED. DELAMINATION MOST LIKELY OCCURRED DUE TO HYDRATION OF THE PATCH FOR 5 MINUTES, EXCEEDING THE RECOMMENDED HYDRATION TIME INDICATED IN THE IFU OF 1-2 MINUTES. MANUFACTURING RECORDS FOR LOT M15E1118 HAVE BEEN REVIEWED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES FOUND DURING THE REVIEW. THIS IS THE ONLY COMPLAINT ASSOCIATED WITH LOT M15E118 TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 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 DELAMINATION OF THE ECM LAYERS WAS OBSERVED DURING SUTURING. THE PATCH WAS HYDRATED FOR 5 MINUTES IN SALINE PRIOR TO USE. IT WAS REPORTED THAT THE SURGEON HAD ALMOST COMPLETELY SEWN IN THEGRAFT, WHEN RIPPING AT THE SUTURE LINE WAS OBSERVED. THE SURGEON ATTEMPTED TO REINFORCE WITH ADDITIONAL SUTURE, BUT EVENTUALLY REMOVED THE GRAFT AND USED ANOTHER PRODUCT. IT WAS REPORTED THAT ADDITIONAL SURGICAL TIME WAS REQUIRED IN ORDER TO REMOVE ADN REPLACE THE GRAFT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445924 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET, INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-0813-609 M15E1118

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR