BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 3819971 · Received May 14, 2014

    Report

    Report Number
    3005619880-2014-00024
    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 NO AVAILABLE, THE REPAIR WAS LIKELY PERFORMED USING THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR, WHICH IS INDICATED FOR USE AAS AN INTRACARDIAC PATCH OR PLEDGET FOR TISSUE REPAIR (I.E., ATRIAL SEPTAL DEFECT (ASD), VENTRICULAR SEPTAL DEFECT (VSD), ETC.) AND SUTURE-LINE BUTTRESSING. EXACT DETAILS REGARDING THE IMPLANT AND EXPLANT PROCEDURE ARE CURRENTLY UNAVAILABLE. THE ARTICLE GENERALIZED THE IMPLANTATION PROCESS FOR ALL MITRAL VALVE REPAIR CASES AS FOLLOWS: THE PATCH WAS REHYDRATED 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 CARDIOVASCULAR 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 CONGENIAL HEART DISEASE: HISTOLOGIC EVAL 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 4 (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 INFERIOR LEAFLET AUGMENTATION IN A (B)(6) WITH A RIGHT DOMINANT CAVC (COMMON ATRIOVENTRICULAR CANAL). THE PATCH REMAINED IN SITU FOR 7 DAYS AND WAS THEN EXPLANTED DURING A SECONDARY PROCEDURE DUE TO RESIDUAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288744 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PELDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention