BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 3819997 · Received May 14, 2014

    Report

    Report Number
    3005619880-2014-00025
    Event Type
    Injury
    Date Received
    May 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETUNED FOR EVALUATION. CORMATRIX HAS REQUESTED ADDITIONAL INFO FROM THE PAPER'S AUTHORS REGARDING THIS EVENT. ALTHOUGH THE EXACT PRODUCT INFO WAS NOT AVAILABLE, THE REPAIR WAS LIKELY PERFORMED USING THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR, WHICH IS INDICATED FOR USE AS A INTRACARDIAC PATCH OR PLEDGET FOR TISSUE REPAIR (I.E., ATRIAL SEPTAL DEFECT (ASD), VENTRICULAR SEPTAL DEFECT (VSD), ETC] AND SUTURE-LINE BUTTRESSING. THE IFU FOR THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR LISTS A POTENTIAL COMPLICATION AS "ACUTE AND CHRONIC INFLAMMATION." EXACT DETAILS REGARDING THE IMPLANT AND EXPLANT PROCEDURES ARE CURRENTLY UNAVAILABLE. THE ARTICLE GENERALIZED THE IMPLANTATION PROCESS FOR ALL MITRAL VALVE REPAIR CASES AS FOLLOWS: THE PATCH WAS REHYDRATED FOR 10 MINUTES, CUT TO THE APPROPRIATE SIZE AND SHAPE, AND WAS SEWN INTO PLACE WITH 7-0 PROLENE SUTURE. MITRAL VALVE REPAIRS MAINLY INVOLVED AUGMENTATION OF THE "BELLY" OF THE VALVE LEAFLET, WITH MAINTENANCE OF THE EDGE SUPPORT STRUCTURES.

    Description of Event or Problem · 1

    ON (B)(4) 2014, CORMATRIX CARDIOVASCULARE RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF A CORMATRIX ECM DEVICE FOR VALVULOPLASTY OF THE MITRAL VALVE. A JOURNAL ARTICLE TITLED, "PRELIMINARY EXPERIENCE WITH PORCINE INTESTINAL SUBMUCOSA (CORMATRIX) FOR VALVE RECONSTRUCTION IN CONGENITAL HEART DISEASE: HISTOLOGICAL EVALUATION OF EXPLANTED VALVES" PUBLISHED ON-LINE ON 03/01/2014 IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY WAS DISCOVERED DURING A PERIODIC LITERATURE REVIEW. ALL SURGICAL PROCEDURES DESCRIBED WITHIN THE ARTICLE WERE PERFORMED FROM "FEBRUARY 2006 TO FEBRUARY 2013." THIS REPORT IS BEING SUBMITTED TO DOCUMENT CASE INFO FOR PT NUMBER 5 (TABLE 4 FROM THE ARTICLE). DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT CORMATRIX ECM MATERIAL WAS USED FOR A MITRAL VALVE ANTERIOR LATERAL LEAFLET AUGMENTATION IN A 2 YEAR OLD WITH A CAVC (COMMON ATRIOVENTRICULAR CANAL). IN 85 DAYS LATER, SURGERY WAS PERFORMED TO ADDRESS DEHISCENCE OF THE PATCH ON THE ANTERIOR LEAFLET. THE PATCH REMAINED IN SITU FOR A TOTAL OF 101 DAYS AND WAS THEN EXPLANTED DURING AN ADDITIONAL PROCEDURE DUE TO PATCH DEHISCENCE AND REGURGITATION. HISTOLOGY RESULTS OF THE EXPLANTED TISSUE EXHIBITED SIGNS OF SEVERE INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288905 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention