BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CAROTID REPAIR

    MDR report key: 4121846 · Received September 18, 2014

    Report

    Report Number
    3005619880-2014-00050
    Event Type
    Injury
    Date Received
    September 18, 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 INFORMATION PROVIDED INDICATED THAT THE RESTENOSIS WAS POSSIBLY DUE TO A CLAMP INJURY. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. NO SAMPLE WAS RETURNED FOR EVALUATION.

    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 RESTENOSIS. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT THE CORMATRIX ECM FOR CAROTID REPAIR WAS USED TO CAROTID ENDARTERECTOMY ANGIOPLASTY. THE PATIENT EXPERIENCED RESTENOSIS POSSIBLY DUE TO A CLAMP INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579670 CORMATRIX ECM FOR CAROTID REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention