BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    MDR report key: 2314811 · Received October 26, 2011

    Report

    Report Number
    3005619880-2011-00004
    Event Type
    Injury
    Date Received
    October 26, 2011
    Date of Event
    September 24, 2011
    Report Date
    September 26, 2011
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K051405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORMATRIX CARDIOVASCULAR CONTACTED THE PHYSICIAN TO REVIEW THE PRODUCT LABELING AND REITERATE THE IMPORTANCE OF SEWING THE CORMATRIX ECM MATERIAL ONLY TO VIABLE TISSUE, NOT TO HOMOGRAFTS. THE CORMATRIX ECM FOR PERICARDIAL CLOSURE IS ONLY INDICATED FOR RECONSTRUCTION AND REPAIR OF THE PERICARDIUM. ALTHOUGH CORMATRIX HAS 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 ECM PRODUCTS ARE IDENTICAL IN COMPOSITION AND MANUFACTURING PROCESSING, WITH THE EXCEPTION OF BEING DIFFERENT SIZES AND HAVING DIFFERENT INDICATIONS FOR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN EVENT WAS REPORTED TO CORMATRIX CARDIOVASCULAR INVOLVING A PSEUDOANEURYSM OF THE CORMATRIX ECM FOR PERICARDIAL CLOSURE. THE PT HAD A HISTORY OF PULMONARY ATRESIA WITH PULMONARY ARTERIES ARISING FROM THE AORTA. THE CORMATRIX ECM FOR PERICARDIAL CLOSURE AND BEEN USED DURING THE INITIAL OPERATION AS A HOOD FOR THE RV-PA CONDUIT (PULMONARY HOMOGRAFT). AT THE TIME OF IMPLANT, THE CORMATRIX ECM PATCH HAD BEEN SEWN TO A HOMOGRAFT. UPON RE-ENTRY, THE PHYSICIAN OBSERVED A HOLE WHERE THE CORMATRIX ECM HAD BEEN IMPLANTED. SURGICAL REPAIR WAS COMPLETED USING GORTEX MATERIAL. THE PHYSICIAN STATED THAT THE PT IS DOING WELL. THE CAUSE OF THE CORMATRIX ECM BECOMING PSEUDOANEURYSMAL IS UNK; HOWEVER, IT IS BELIEVED THAT SUTURING THE CORMATRIX ECM TO THE HOMOGRAFT CONTRIBUTED TO THIS EVENT. AS STATED IN THE INSTRUCTIONS FOR USE (PN 20058-03081) THE CORMATRIX ECM PRODUCT MUST BE SUTURED TO VIABLE NATIVE TISSUE AND MUST NOT BE SUTURED TO HOMOGRAFTS, SYNTHETIC, OR CHEMICALLY CROSS-LIKED MATERIALS.

    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 17 MO Required Intervention