BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 3870086 · Received April 28, 2014

    Report

    Report Number
    3005619880-2014-00018
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K111187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE DELAMINATION IS UNK. NO SAMPLE WAS RETURNED FOR EVAL. THE INSTRUCTIONS FOR USE FOR THE CORMATRIX ECM FOR CAROTID REPAIR STATES, "IF DELAMINATION IS OBSERVED, DO NOT IMPLANT THE CORMATRIX ECM".

    Description of Event or Problem · 1

    ON (B)(6) 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 (B)(6) YEAR OLD MALE PT HAD A CAROTID ENDARTERECTOMY ANGIOPLASTY WITH CORMATRIX ECM FOR CAROTID REPAIR ON (B)(6) 2014. THE ECM PATCH WAS SOAKED FOR APPROXIMATELY 1 MINUTE, 30 SECONDS IN SALINE AND WAS THEN PLACED ONTO A STERILE SURGICAL TOWEL PRIOR TO USE. THE SURGEON INDICATED THAT THE ECM HAD DELAMINATED IN A SMALL AREA BUT CONTINUED TO USE AND SUTURE THE PATCH INTO PLACE. THERE WERE NO PROCEDURAL DELAYS OR OTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254083 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-006-609 M14B1016

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR