BEUDAMED
    FDA Adverse Event Other Summary report: N

    BG3000-G-UNKNOWN CONFIGURATION

    MDR report key: 1003518 · Received February 18, 2008

    Report

    Report Number
    1063481-2008-00004
    Event Type
    Other
    Date Received
    February 18, 2008
    Report Date
    February 13, 2008
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE JOURNAL ARTICLE, "CUSTOM-TAILORED VALVE CONDUIT FOR COMPLEX AORTIC ROOT DISEASE", THE DESTRUCTION OF THE AORTIC ANNULUS WAS DUE TO THE REMOTE APPLICATION OF BIOGLUE DURING AORTIC ROOT REPLACEMENT IN TWO PATIENTS. AS SUCH, AN INVESTIGATION WAS CONDUCTED AND CRYOLIFE'S FINDINGS ARE DESCRIBED BELOW. CORRESPONDENCE BETWEEN THE AUTHOR OF THE ARTICLE AND CRYOLIFE WAS CONDUCTED. THE TWO PATIENTS UNDERWENT PREVIOUS PROCEDURES WHERE BIOGLUE WAS USED TO CONTROL BLEEDING BETWEEN THE GRAFT AND THE AORTIC ANNULUS IN A ROOT REPLACEMENT PROCEDURE. THE AUTHOR STATED THAT THE JOURNAL ARTICLE " HAS NOTHING TO DO WITH CRYOLIFE" AND THAT HE " HAS NEVER USED BIOGLUE". WITH THE AVAILABLE INFO, NO CONCLUSION REGARDING THE EXACT CAUSE OF THE EVENT CAN BE DRAWN AT THIS TIME. HOWEVER, IT APPEARS THAT THE SURGEON REMOVED THE TISSUE WHERE BIOGLUE WAS PREVIOUSLY APPLIED TO ALLOW FOR THE PLACEMENT OF A NEW GRAFT AND NOT DUE TO BIOGLUE DESTROYING THE AORTIC ANNULUS.

    Description of Event or Problem · 1

    ACCORDING TO THE JOURNAL ARTICLE, "CUSTOM-TAILORED VALVE CONDUIT FOR COMPLEX AORTIC ROOT DISEASE", THE DESTRUCTION OF THE AORTIC WAS DUE TO THE REMOTE APPLICATION OF BIOGLUE DURING AORTIC ROOT REPLACEMENT IN TWO PATIENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention