BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 4920934 · Received July 15, 2015

    Report

    Report Number
    3005619880-2015-00039
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    June 18, 2015
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED FOR THIS SPECIFIC PT. THE DEVICE REMAINS IMPLANTED. ADD'L INFO WAS REQUESTED ON (B)(4) 2015. NO ADD'L INFO IS CURRENTLY AVAILABLE. IT IS UNK IF THE REPORTED COMPLICATION MAY ALSO BE RELATED TO PT CO-MORBIDITIES, THE SURGICAL PROCEDURE, OTHER DEVICES, OR TREATMENTS. ALTHOUGH THE EVENT PRODUCT INFO 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 PULMONARY VALVE IS NOT AN APPROVED OR CLEARED INDICATION. THIS IS CONSIDERED AN OFF-LABEL USE OF THE CORMATRIX ECM FOR THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR.

    Description of Event or Problem · 1

    AN ARTICLE TITLED, "EARLY AND MID-TERM CLINICAL EXPERIENCE WITH EXTRACELLULAR MATRIX SCAFFOLD FOR CONGENITAL CARDIAC WAS VASCULAR RECONSTRUCTIVE SURGERY: A MULTICENTRIC ITALIAN STUDY" WAS PUBLISHED APRIL 16, 2015 IN THE JOURNAL, INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY. THIS ARTICLE WAS DISCOVERED DURING A PERIODIC LITERATURE REVIEW. THE STUDY INCLUDES AN EVAL OF 103 PTS WHO UNDERWENT SURGICAL REPAIR FOR CONGENITAL HEART DISEASE USING CORMATRIX ECM. THE STUDY WAS PERFORMED TO ASSESS THE OPTIMAL INDICATION FOR THE MATERIAL. ALL SURGICAL PROCEDURES DESCRIBED WITHIN THE ARTICLE WERE PERFORMED SOMETIME BETWEEN AUGUST 2009 AND JANUARY 2014. ON (B)(6) 2015, CORMATRIX WAS ABLE TO SPEAK DIRECTLY WITH THE CORRESPONDING AUTHOR OF THE ARTICLE. DURING THE DISCUSSION, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT (NOT PREVIOUSLY REPORTED) INVOLVING THE USE OF A CORMATRIX ECM DEVICE AS DESCRIBED BELOW: IT WAS REPORTED THAT CORMATRIX ECM WAS USED TO FABRICATE AND REPLACE A PULMONARY VALVE. THE PT LATER REQUIRED A CATHETER REINTERVENTION DUE TO STENOSIS OF THE PULMONARY VALVE. NO FURTHER COMPLICATIONS WERE REPORTED. ALTHOUGH THE EXACT PRODUCT INFO 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 PULMONARY VALVE IS NOT AN APPROVED OR CLEARED INDICATION. THIS IS CONSIDERED AN OFF-LABEL USE OF THE CORMATRIX ECM FOR THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460681 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention