BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 3908030 · Received June 13, 2014

    Report

    Report Number
    3005619880-2014-00035
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K111187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE STENOSIS IS CURRENTLY UNK.

    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 AND A REPORTED CASE OF RECURRENT STENOSIS. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT AN (B)(6) MALE PT HAD A LEFT INTERNAL CAROTID ENDARTERECTOMY ON (B)(6), 2013. AT THE F/U 1-3 MONTHS VISIT, STENOSIS WAS FOUND TO BE 60-79%. AT THE F/U 6 MONTH VISIT ON (B)(6), 2014, STENOSIS WAS FOUND TO BE 80-99%. A LEFT INTERNAL CAROTID ARTERY STENT WAS PLACED FOLLOWED BY BALLOON ANGIOPLASTY ON (B)(6), 2014. THE PT WAS TAKEN TO RECOVERY IN STABLE CONDITION AND MEDICAL RECORDS INDICATE THAT THE STENOSIS HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351161 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-006-606 M13E1054

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention