BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 6846868 · Received September 6, 2017

    Report

    Report Number
    3005619880-2017-00025
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 2, 2017
    Report Date
    September 6, 2017
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    UDI-DI
    10859389005147
    PMA / PMN Number
    K140789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR EVALUATION. A REVIEW OF THE COMPLAINT LOG SHOWS THAT THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE REPORTED LOT NUMBER. MANUFACTURING REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT SHOWS THAT ALL UNITS WERE QUALITY RELEASED ON 6/12/2017 HAVING MET ALL INTERNAL QC ACCEPTANCE REQUIREMENTS. ALL STERILIZATION RECORDS, AND BIOBURDEN TESTING INDICATE SUCCESSFUL STERILIZATION PROCESS, AND PASSING "LAL" AND PRODUCT STERILITY RESULTS ALLOWED THE LOT TO BE RELEASED HAVING MET ALL CRITERIA FOR MANUFACTURING RELEASE. A REVIEW OF SUPPLIER COMPONENT LOTS USED IN THE BUILD FOR THE LOT LISTED ABOVE REFLECTED NON-CONFORMANCES ASSOCIATED WITH THE COMPONENT LOT USED, HOWEVER THESE UNITS WERE REMOVED FROM THE LOT PRIOR TO THE SUPPLIER SHIPMENT AND CORMATRIX INSPECTION, SO THERE WAS NO IMPACT ON THE REPORTED ISSUE. IT WAS STATED THAT THE PATCH WAS SOAKED FOR 10 MINUTES. PER THE IFU THAT WAS PACKAGED WITH THE LOT (PART #20438-032514) IT STATES UNDER "WARNINGS AND PRECAUTIONS: EXCESSIVE HYDRATION MAY RESULT IN DELAMINATION. IF DELAMINATION IS OBSERVED, DO NOT USE THE CORMATRIX ECM." ALSO UNDER "SUGGESTED INSTRUCTIONS FOR USING THE CORMATRIX ECM: 3. HYDRATE THE CORMATRIX ECM BY PLACING IT IN A BOWL OF STERILE SALINE OR OTHER ISOTONIC SOLUTION FOR APPROXIMATELY 1-2 MINUTES PRIOR TO USE." THE EXACT ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER EXCESSIVE HYDRATION TIMES ABOVE THE RECOMMENDATION FROM THE IFU COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE HAD A FEMORAL ENDARTERECTOMY ON (B)(6) 2017 USING MODEL #CMCV-014-609, LOT # M17E1119. PER THE FACILITY, "THE PATCH WAS OPENED AND PLACED ON THE BACK TABLE TO SOAK. ACCORDING TO THE TECH, ABOUT 10 MINUTES LAPSED (WHILE THE ECM WAS SOAKING IN SALINE SOLUTION) BEFORE THE SURGEON WAS READY TO SUTURE THE PATCH. AS HE WAS BEGINNING TO SEW IN THE PATCH, THE PRODUCT BEGAN TO DELAMINATE ALONG ONE OF THE ENDS AND THEN PEELED APART EASILY. THE ECM PATCH WAS DISCARDED. A NEW PATCH WAS OPENED, SOAKED FOR 1 MINUTE, AND SUTURED WITHOUT INCIDENT. THERE WERE NO OBVIOUS REPERCUSSIONS FOR THE PATIENT OTHER THAN ADDING 10 MINUTES TO THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626779 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-014-609 M17E1119 10859389005147

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention