BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL ABSORBABLE HEMOSTAT

    MDR report key: 1490832 · Received September 25, 2009

    Report

    Report Number
    2210968-2009-01085
    Event Type
    Death
    Date Received
    September 25, 2009
    Date of Event
    June 17, 2009
    Report Date
    August 27, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/24/2009. CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING X4, AORTIC VALVE REPLACEMENT, AND LEFT CAROTID ENDARTERECTOMY IN 2009. AT THE COMPLETION OF THE SURGERY, THE HEART WAS DE-AIRED AND THE PT WAS WEANED FROM CARDIOPULMONARY BYPASS. THERE WAS BLEEDING FROM THE REGION OF THE OM GRAFT WHICH WAS OVER SEWED WITH PROLENE WHICH REDUCED THE BLEEDING. THE FIBRILLAR ABSORBABLE HEMOSTAT AND FLOSEAL WERE UTILIZED AS PACKING IN THIS AREA TO CONTROL BLEEDING. THE PT HAD GLOBAL BIVENTRICULAR DYSFUNCTION WHICH WAS UNRESPONSIVE TO EPINEPHRINE. CPR WAS INITIATED AND THE PT WAS SUPPORTED BY BYPASS. THE PT'S EEG WAS FLAT AND IT WAS DETERMINED THAT IT WAS AN IRREVERSIBLE SITUATION AND THE PT WAS DECLARED DEAD. THE AUTOPSY REPORT WHICH WAS PROVIDED TO BAXTER STATES "EMBOLIZATION OF FOREIGN MATERIAL CONSISTENT WITH MANUFACTURED PRO-THROMBOTIC MATERIAL INTO THE CORONARY CIRCULATION, WITH INVOLVEMENT OF NUMEROUS INTRAMYOCARDIAL AND EPICARDIAL VESSELS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| R FLOSEAL