BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 3880819 · Received April 9, 2014

    Report

    Report Number
    3005619880-2014-00016
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K111187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE DELAMINATION IS UNK. NO SAMPLE WAS RETURNED TO EVAL. THE CORMATRIX SALES REP WHO WAS PRESENT DURING THE PROCEDURE RECOMMENDED THAT THE SURGEON USED A NEW PATCH. THE SURGEON OPTED TO CONTINUE TO IMPLANT THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(4) 2014, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR CAROTID REPAIR. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT A MALE PT HAD A CAROTID ENDARTERECTOMY ANGIOPLASTY WITH CORMATRIX ECM FOR CAROTID REPAIR ON (B)(6) 2014. THE ECM PATCH WAS SOAKED FOR 1 MINUTE IN ROOM TEMPERATURE SALINE AND WAS THEN PLACED ONTO A STERILE SURGICAL TOWEL FOR APPROX 3 MINUTES BEFORE BEING USED. THE SURGEON SEWED THE PATCH INTO PLACE CIRCUMFERENTIALLY USING 6.0 PROLENE SUTURES. AFTER THE PATCH WAS APPROX 90% SEWN INTO PLACE, DELAMINATION IN A SMALL AREA ALONG ONE EDGE WAS VISIBLE AND COMMENTED ON BY THE SURGEON. THE CORMATRIX SALES REP WHO WAS PRESENT DURING THE PROCEDURE RECOMMENDED THAT THE SURGEON USE A NEW PATCH. THE SURGEON INDICATED THAT HE WAS NOT CONCERNED AND CONTINUED TO SUTURE THE PATCH INTO PLACE TAKING FULL BITES THROUGH ALL OF THE LAYERS. THERE WERE NO PROCEDURAL DELAYS OR OTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214026 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-006-609 M13M1115

    Patients

    Seq Age Sex Outcome Treatment
    1