BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 3820001 · Received May 14, 2014

    Report

    Report Number
    3005619880-2014-00027
    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 RETURNED FOR EVAL. CORMATRIX HAS REQUESTED ADD'L INFO FROM THE PAPER'S AUTHORS REGARDING THIS EVENT. THE RELATIONSHIP BETWEEN THE DEVICE AND REASON FOR EXPLANT IS CURRENTLY UNK. 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 AN 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 OR CHRONIC INFLAMMATION." THE IFU ALSO STATES, "DEVICE MUST BE SUTURED TO VIABLE NATIVE TISSUE" AND "PLACE THE EDGE OF THE CORMATRIX ECM IN CONTACT WITH VIABLE TISSUE." EXACT DETAILS REGARDING THE IMPLANT PROCEDURE IS CURRENTLY UNAVAILABLE. THE ARTICLE GENERALIZED THE IMPLANTATION PROCESS 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. A VARIETY OF IMPLANTATION TECHNIQUES WERE USED FOR AORTIC VALVE REPAIR, INCLUDING LEAFLET EDGE AUGMENTATION, ENLARGEMENT OF THE BELLY OF THE LEAFLET, OR COMPLETE LEAFLET REPLACEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING THE USE OF A CORMATRIX ECM DEVICE FOR VALVULOPLASTY OF THE AORTIC VALVE. A JOURNAL ARTICLE TITLED, "PRELIMINARY EXPERIENCED WITH PORCINE INTESTINAL SUBMUCOSA (CORMATRIX) FOR VALVE RECONSTRUCTION IN CONGENITAL HEART DISEASE: HISTOLOGIC EVAL OF EXPLANTED VALVES" PUBLISHED ON-LINE ON MARCH 1, 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 "(B)(6) 2006 TO (B)(6) 2013." THIS REPORT IS BEING SUBMITTED TO DOCUMENT CASE INFO FOR PATIENT NUMBER 10 (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 REPAIR OF A PERFORATED POSTERIOR LEAFLET IN A 3.4 YEAR OLD WITH BORDERLINE HLHS (HYPOPLASTIC LEFT HEART SYNDROME), AORTIC STENOSIS, MITRAL STENOSIS, AND HYPOPLASTIC ARCH. THE PATCH REMAINED IN SITU FOR 114 DAYS AND WAS THEN EXPLANTED DURING A SECONDARY PROCEDURE DUE TO MARKED THICKENING OF LEAFLETS. HISTOLOGY RESULTS OF THE EXPLANTED TISSUE EXHIBITED SIGNS OF SEVERE INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289058 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention