BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 4122405 · Received September 18, 2014

    Report

    Report Number
    3005619880-2014-00047
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 2, 2014
    Report Date
    August 20, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K111187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON INDICATED THAT THE PATIENT'S ARTERIAL WALL HAD THICKENED AND THE RESTENOSIS WAS NOT RELATED TO THE CORMATRIX ECM PATCH. A SMALL AREA OF THE EXPLANTED ECM WAS SUBMITTED TO CORMATRIX FOR EVALUATION AND RECEIVED ON (B)(4) 2014. TISSUE HISTOLOGY TESTING IS CURRENTLY IN PROCESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR CAROTID REPAIR AND A REPORTED CASE OF RESTENOSIS. ON (B)(6) 2014,, CORMATRIX WAS ABLE TO SPEAK DIRECTLY WITH THE SURGEON INVOLVED IN THE CASE. DETAILS OF THE EVENT ARE REPORTED BELOW. IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT HAD A RIGHT SIDE ENDARTERECTOMY ANGIOPLASTY WITH CORMATRIX ECM FOR CAROTID REPAIR ON (B)(6) 2013. THE PATCH WAS HYDRATED, TAPERED ON EACH END, AND THEN SUTURED ONTO PLACE USING PROLENE SUTURES FROM THE DISTAL COMMON THROUGH BIFURCATION AND APPROXIMATELY 2 CM INTO THE INTERNAL CAROTID ARTERY. IT WAS ESTIMATED THAT THE IMPLANTED PATCH WAS APPROXIMATELY 4 1/2 TO 5 CM IN LENGTH. NO BIOGLUE OR HEMOSTATIC AGENTS WERE USED DURING THE PROCEDURE. IN (B)(6) 2014, A CAROTID DUPLEX IDENTIFIED RESTENOSIS OF 80% AND BLOOD VELOCITY OF 113. ON (B)(6) 2014, THE ENTIRE ECM PATCH WAS REMOVED AND REPLACED WITH BOVINE PERICARDIUM. THERE WAS NO PLAQUE OR THROMBUS PRESENT AT THE SITE OF THE ENDARTERECTOMY. THE PATCH APPEARED THIN IN COMPARISON TO THE PATIENT'S ARTERIAL WALL WHICH HAD THICKENED POSTERIORLY, MEDIALLY, AND ADJACENT TO THE ECM PATCH. THE SURGEON INDICATED THAT THE RESTENOSIS WAS NOT PATCH RELATED BUT A RESULT OF THICKENING OF THE PATIENT'S OWN TISSUE. A SMALL SAMPLE WAS TAKEN FROM CLOSE TO THE CENTER OF THE PATCH AND SUBMITTED TO CORMATRIX FOR HISTOPATHOLOGY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579322 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET, INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-006-609 M12M1117

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention