BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    MDR report key: 4697074 · Received April 14, 2015

    Report

    Report Number
    3005619880-2015-00013
    Event Type
    Injury
    Date Received
    April 14, 2015
    Date of Event
    February 13, 2015
    Report Date
    March 17, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K051405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT IS UNKNOWN. THE EXPLANTED PRODUCT WAS NOT RETURNED TO CORMATRIX FOR INVESTIGATION. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. MANUFACTURING RECORDS FOR CORMATRIX LOT MC14C1027 WERE REVIEWED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES ASSOCIATED WITH THIS LOT. THE CORMATRIX ECM FOR PERICARDIAL CLOSURE IS INDICATED FOR RECONSTRUCTION AND REPAIR OF THE PERICARDIUM. ALTHOUGH CORMATRIX HAS CLEARANCE FOR USE AS AN INTRACARDIAC PATCH OR PLEDGET FOR CARDIAC TISSUE REPAIR (CORMATRIX ECM FOR CARDIAC TISSUE REPAIR K063349), THE CORMATRIX ECM FOR PERICARDIAL CLOSURE PRODUCT (K051405) WAS USED ON THIS PATIENT. IT SHOULD BE NOTED THAT THE TWO ECM PRODUCTS ARE IDENTICAL IN COMPOSITION AND MANUFACTURING PROCESSING, WITH THE EXCEPTION OF PATCH SIZE AND HAVING DIFFERENT INDICATIONS FOR USE.

    Description of Event or Problem · 1

    ON (B)(4) 2015, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR PERICARDIAL CLOSURE. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT THE CORMATRIX ECM WAS USED TO REPAIR A LEFT VENTRICULAR ANEURYSM ON (B)(6) 2014 USING A TECHNIQUE SIMILAR TO A DOR PROCEDURE. THE PATCH MATERIAL WAS PREPARED PER THE INSTRUCTIONS FOR USE AND SEWN INTO PLACE USING PROLENE SUTURE WITH INTERRUPTED STITCHES. THE SURGEON INDICATED THAT THE ANEURYSM WAS VERY LARGE. APPROXIMATELY 2 - 2 1/2 CENTIMETERS IN DIAMETER. SIX MONTHS FOLLOWING THE PROCEDURE, A RE-OPERATION WAS REQUIRED. THE SURGEON INDICATED THAT THE ECM PATCH HAD REMODELED FINE AROUND THE SUTURE LINE AREA; HOWEVER, THE CENTER OF THE PATCH WAS FOUND TO HAVE LARGE FENESTRATIONS THROUGHOUT. THE SUTURE LINE WAS CAREFULLY EXAMINED AND EACH SUTURE WAS INTACT. THE ECM PATCH WAS EXCISED ON FEBRUARY 13, 2015 AND REPLACED WITH A SYNTHETIC PATCH. IT WAS REPORTED THAT THE PATIENT IS DOING FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247470 CORMATRIX ECM FOR PERICARDIAL CLOSURE PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-003-402 M14C1027

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention