BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    MDR report key: 4951514 · Received July 28, 2015

    Report

    Report Number
    3005619880-2015-00040
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 29, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED BY CORMATRIX ON 06/30/2015. THE EXPLANTED ECM VALVE WAS VISUALLY INSPECTED. THE VALVE APPEARED INTACT WITH NO SIGNS OF DAMAGE OR MATERIAL RUPTURE. HISTOLOGY EVALUATION IS CURRENTLY IN PROCESS. BASED ON INITIAL SAMPLE INSPECTION AND CLINICAL CASE INFORMATION, THE VALVE FAILURE OCCURRED AS A RESULT OF A RUPTURE OF THE PATIENT'S CHORDAE TENDINEAE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN FINAL SAMPLE EVALUATION IS COMPLETE. ALTHOUGH THE EXACT PRODUCT INFORMATION IS 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 USE OF THE CORMATRIX ECM TO FABRICATE A MITRAL VALVE IS NOT AN APPROVED OR CLEARED INDICATION. THIS IS CONSIDERED AN OFF-LABEL USE OF THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IS INCLUDED IN THIS SUPPLEMENTAL REPORT. FINAL DEVICE EVALUATION RESULTS ARE PROVIDED BELOW: THE MITRAL VALVE FABRICATED FROM ECM WAS REMOVED INTACT ON (B)(6) 2015 AND REPLACED WITH A MECHANICAL VALVE. THE SAMPLE WAS RETURNED FOR EVALUATION AND RECEIVED BY CORMATRIX ON JUNE 30, 2015. THE EXPLANTED ECM VALVE WAS VISUALLY INSPECTED. THE VALVE APPEARED INTACT WITH NO SIGNS OF DAMAGE OR MATERIAL RUPTURE. A LEAFLET WAS TRIMMED, PROCESSED AND EMBEDDED IN PARAFFIN. THE SAMPLE WAS SECTIONED AND STAINED WITH AN H&E AND A MASSON STAIN. HISTOLOGY EVALUATION WAS COMPLETED ON OCTOBER 12, 2015. THE SAMPLE EVALUATION CONCLUDED THAT THE FABRICATED VALVE SPECIMEN LACKED AN ORGANIZED ENDOTHELIAL LINING, CELL INFILTRATION, AND NEOVASCULARIZATION. AT THE POINT OF TISSUE COLLECTION, THERE APPEARS TO BE NO INFLAMMATORY RESPONSE AND NO RESIDENT INFLAMMATORY CELLS. DELAMINATION IS VISIBLE THROUGHOUT THE SAMPLE AND THE PRESENCE OF RED BLOOD CELLS SUGGESTS BLOOD ACCUMULATED WITHIN THESE SPACES. BANDS OF THE ECM WERE WELL ORGANIZED, BUT THE SPECIMEN APPEARED TO HAVE DEGRADED IN THE MIDDLE REGION. OVERALL, FINDINGS ARE CONSISTENT WITH EXPECTATIONS FOR REMODELING AT THIS TIME POINT. BASED ON INITIAL SAMPLE INSPECTION AND CLINICAL CASE INFORMATION, THE VALVE FAILURE OCCURRED AS A RESULT OF A RUPTURE OF THE PATIENT'S CHORDAE TENDINEAE. THE USER FACILITY REPORTED THAT THE VALVE WAS FABRICATED FROM CORMATRIX ECM FOR PERICARDIAL CLOSURE, LOT M14L1133. MANUFACTURING RECORDS FOR LOT M14L1133 WERE REVIEWED. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE ONLY EVENT ASSOCIATED WITH LOT M14L1133 TO DATE. THE CORMATRIX ECM FOR PERICARDIAL CLOSURE IS INDICATED FOR THE RECONSTRUCTION AND REPAIR OF THE PERICARDIUM. THE USE OF THE CORMATRIX ECM TO FABRICATE A MITRAL VALVE IS NOT AN APPROVED OR CLEARED INDICATION. THIS IS CONSIDERED AN OFF-LABEL USE OF THE CORMATRIX ECM FOR PERICARDIAL CLOSURE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, CORMATRIX CARDIOVASCULAR RECEIVED DETAILS OF AN EVENT INVOLVING A VALVE FABRICATED FROM CORMATRIX ECM MATERIAL. DETAILS OF THE EVENT ARE PROVIDED BELOW. IT WAS REPORTED THAT THE CORMATRIX ECM WAS USED TO FABRICATE A TRI-LEAFLET HEART VALVE. THE VALVE WAS THEN PLACED IN THE MITRAL POSITION. APPROXIMATELY 8 WEEKS FOLLOWING IMPLANT, THE VALVE BECAME FLAIL. IT WAS REPORTED THAT THE PATIENT'S CHORDAE TENDINEAE RUPTURED. THE ECM VALVE WAS REMOVED INTACT ON (B)(6) 2015. ALTHOUGH THE EXACT PRODUCT INFORMATION IS 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 USE OF THE CORMATRIX ECM TO FABRICATE A MITRAL VALVE IS NOT AN APPROVED OR CLEARED INDICATION. THIS IS CONSIDERED AN OFF-LABEL USE OF THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490636 CORMATRIX ECM FOR PERICARDIAL CLOSURE PATCH, PLEDGET, AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-003-402 M14L1133

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention