BEUDAMED
    FDA Adverse Event Death Summary report: N

    BG3000-G-BIOGLUE UNKNOWN CONFIRGURATION

    MDR report key: 949516 · Received November 15, 2007

    Report

    Report Number
    1063481-2007-00025
    Event Type
    Death
    Date Received
    November 15, 2007
    Report Date
    November 5, 2007
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDICAL REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. BIOGLUE IS STERILIZED VIA VALIDATED STERILIZATION PROCEDURE USING GAMMA IRRADIATION. IT IS NOT LIKELY THAT BIOGLUE WOULD CAUSE OR CONTRIBUTE TO A SYSTEMIC INFECTION. ADDITIONALLY, A SYSTEMIC INFECTION IS A WELL ESTABLISHED POST-OPERATIVE COMPLICATION IN MANY SURGERIES INCLUDING CARDIOVASCULAR AND CARDIOTHORACIC PROCEDURES. THEREFORE, IT IS POSSIBLE THAT THIS DEATH IS A RESULT OF A KNOWN, POTENTIAL POST-OPERATIVE COMPLICATION RELATED TO THE PROCEDURE, RATHER THAN THE DIRECT RESULT OF THE USE OF BIOGLUE. HOWEVER, WITH THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME... MANUFACTURER DID NOT RECEIVE FORM 3500A FROM USER. THIS REPORT IS CLOSED, UNLESS OTHERWISE SPECIFIED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, DURING CORRESPONDENCE WITH A SURGEON CRYOLIFE REPRESENTATIVES WERE INFORMED THAT APPROXIMATELY 3 TO 5 YEARS AGO TWO PATIENTS DIED AND THE SURGEON ATTRIBUTED THE DEATHS TO THE USE OF BIOGLUE. SPECIFICALLY, DURING AN UNSPECIFIED CARDIAC PROCEDURE BIOGLUE (LOT NUMBER UNKNOWN) WAS APPLIED. SUBSEQUENTLY, THE PATIENT DIED OF SYSTEMIC INFECTION. THE SURGEON WAS NOT WILLING TO ELABORATE ANY FURTHER AND HAS STATED THAT HE DOES NOT WANT TO DISCUSS EITHER CASE. THIS REPORT REPRESENTS THE SECOND OF TWO INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BG3000-G-BIOGLUE UNKNOWN CONFIRGURATION BIOGLUE SURGICAL ADHESIVE MFI CRYOLIFE, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death| O