BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    MDR report key: 1678230 · Received May 7, 2010

    Report

    Report Number
    3005619880-2010-00008
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 11, 2010
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K051405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORMATRIX ECM PRODUCT WAS NOT RETURNED TO CORMATRIX FOR INVESTIGATION. CORMATRIX HAS DISCUSSED THE INCIDENT WITH THE SURGEON WHO PERFORMED THE PROCEDURE. WHILE THE EXACT CAUSE OF THE SUTURE PULL-THROUGH COULD NOT BE DETERMINED, THE SURGEON INDICATED THAT DUE TO THE PHYSIOLOGICAL LOCATION OF THE IMPLANTED ECM, THE SUTURES THAT PULLED THROUGH MAY HAVE BEEN SUBJECTED TO GREATER FORCES THAN NORMALLY EXPECTED. THIS IS THE FIRST EVENT THAT HAS BEEN REPORTED TO CORMATRIX REGARDING THIS TYPE OF FAILURE. THE ECM FOR PERICARDIAL CLOSURE PRODUCT IS ONLY INTENDED FOR THE RECONSTRUCTION AND REPAIR OF THE PERICARDIUM. ALTHOUGH CORMATRIX HAS FDA CLEARANCE FOR USE AS AN INTRACARDIAC PATCH OR PLEDGET FOR CARDIAC TISSUE REPAIR (CORMATRIX ECM FOR CARDIAC TISSUE REPAIR K063349), IT WAS THE CORMATRIX ECM FOR PERICARDIAL CLOSURE PRODUCT (K051405) THAT WAS USED ON THIS PT. IT SHOULD BE NOTED THAT THE TWO PRODUCTS ARE IDENTICAL IN COMPOSITION AND MFG PROCESSING, WITH THE EXCEPTION BEING DIFFERENT SIZES AND DIFFERENT INDICATIONS FOR USE.

    Description of Event or Problem · 1

    ON 04/11/2010, AN EVENT WAS REPORTED TO CORMATRIX CARDIOVASCULAR INVOLVING A REOPERATION THAT SHOWED THAT THE SUTURES USED TO SEW THE CORMATRIX ECM FOR PERICARDIAL CLOSURE INTO PLACE HAD PULLED THROUGH THE ECM MATERIAL IN A SPECIFIC LOCATION. THE CORMATRIX ECM WAS USED TO REPAIR A 2CM X 2CM DEFECT IN THE ANTERIOR MITRAL LEAFLET IN A PT WITH ENDOCARDITIS. THE REPAIR WAS COMPLETED SUCCESSFULLY AND THE PT'S IMMEDIATE POSTOPERATIVE RECOVERY WAS UNEVENTFUL; HOWEVER, TWO TO THREE DAYS POSTOPERATIVELY, A SIGNIFICANT MURMUR AND PULMONARY EDEMA BECAME EVIDENT. AN ECHOCARDIOGRAM REVEALED A MODERATE LEAK AND PATCH DEHISCENCE. THE PT WAS MONITORED FOR FOUR WEEKS BEFORE CLINICAL SIGNS OF CONGESTIVE HEART FAILURE PROMPTED THE PHYSICIAN TO REOPERATE. DURING REOPERATION, THE PHYSICIAN STATED THAT HE OBSERVED THAT THE SUTURES HAD PULLED THROUGH THE EDGE OF THE ECM ALONG 25-30% OF THE ECM. THE PHYSICIAN REPORTED THAT HE EXCISED THE ECM AND SUBSEQUENTLY USED BOVINE PERICARDIUM TO COMPLETE THE REPAIR. TWO WEEKS POST-REOPERATION, THE PHYSICIAN REPORTED THAT THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMATRIX ECM FOR PERICARDIAL CLOSURE PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-003-401

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention