BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORMATRIX ECM FOR CARDIAC TISSUE REPAIR

    MDR report key: 1659882 · Received April 14, 2010

    Report

    Report Number
    3005619880-2010-00004
    Event Type
    Death
    Date Received
    April 14, 2010
    Date of Event
    February 25, 2010
    Report Date
    March 14, 2010
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, A PT DEATH WAS REPORTED TO CORMATRIX CARDIOVASCULAR. THE PHYSICIAN STATED THAT THIS WAS A VERY HIGH RISK PEDIATRIC CASE WHO HAD SEVERE, COMPLEX HEART DEFECTS. THE PT WAS DIAGNOSED WITH TGA (TRANSPOSITION OF THE GREAT ARTERIES) AND KLINEFELTER'S SYNDROME. ON (B) (6) 2010, THE PT HAD UNDERGONE AN ARTERIAL SWITCH OPERATION (ASO) AND REPAIR OF THE LEFT MAIN CORONARY ARTERY. THE CORMATRIX ECM WAS USED FOR PULMONARY ARTERY RECONSTRUCTION AND CORONARY ARTERY REPAIR. THE PHYSICIAN COMMENTED THAT DURING THE ASO PROCEDURE, THERE WAS TOO MUCH TENSION AND A HOLE WAS MADE IN THE ECM. THE PT DIED THE NEXT DAY ((B) (6) 2010) FROM POOR HEART FUNCTION DUE TO ISCHEMIA RELATED TO HIS PREVIOUSLY DIAGNOSED CONDITION. THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PRODUCT WAS NOT RETURNED TO CORMATRIX FOR INVESTIGATION. IT COULD NOT BE DETERMINED WHETHER THE CORMATRIX ECM CONTRIBUTED TO THE PT'S DEATH. AS THE PHYSICIAN STATED, THE PEDIATRIC PT HAD VERY SEVERE HEART DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR PATCH, PLEDGET AND INTRACARDIAC, PETP DXZ CORMATRIX CARDIOVASCULAR, INC. CMCV-002

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Death