BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR VASCULAR REPAIR

    MDR report key: 5654843 · Received May 13, 2016

    Report

    Report Number
    3005619880-2016-00012
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    February 26, 2016
    Report Date
    May 13, 2016
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K140789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE OCCLUSION IS UNKNOWN. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. NO SAMPLE WAS RETURNED FOR EVALUATION. THE INSTRUCTIONS FOR USE FOR THE CORMATRIX ECM FOR VASCULAR REPAIR LISTS RECURRENT STENOSIS AND VESSEL OCCLUSION AS POTENTIAL COMPLICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR VASCULAR REPAIR. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT A PATIENT HAD A CAROTID ENDARTERECTOMY ANGIOPLASTY USING CORMATRIX ECM FOR VASCULAR REPAIR. LATER THE SITE OCCLUDED AND WAS TREATED USING A BALLOON STENT.

    Description of Event or Problem · 1

    ON APRIL 14, 2016, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR VASCULAR REPAIR. IT WAS ORIGINALLY REPORTED THAT A PATIENT HAD A CAROTID ENDARTERECTOMY ANGIOPLASTY USING CORMATRIX ECM FOR VASCULAR REPAIR. LATER THE SITE OCCLUDED AND WAS TREATED USING A BALLOON STENT. ON MAY 24, 2016, ADDITIONAL DETAILS WERE RECEIVED AS FOLLOWS: IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT HAD A RIGHT CAROTID ENDARTERECTOMY USING CORMATRIX ECM FOR VASCULAR REPAIR PATCH ON (B)(6) 2016. A BILATERAL CAROTID DUPLEX ULTRASOUND WAS PERFORMED ON (B)(6) 2016. THE RIGHT INTERNAL CAROTID ARTERY APPEARED TOTALLY OCCLUDED. THE SITE WAS LATER TREATED USING A BALLOON STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307422 CORMATRIX ECM FOR VASCULAR REPAIR PATCH, PLEDGET AND INTRACARDIAC DXZ CORMATRIX CARDIOVASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention