BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1983564 · Received February 10, 2011

    Report

    Report Number
    1063481-2011-00008
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUBLICATION BY DE LA PORTILLA ET AL., THE USE OF BIOGLUE IN THE TREATMENT OF HIGH ANAL FISTULAS RESULTS IN UNACCEPTABLE HIGH RECURRENCE RATES. ALTHOUGH THE AUTHOR PREVIOUSLY DESCRIBED SUCCESS WITH THE USE OF BIOGLUE TO TREAT ANAL FISTULAS, HE REVISITED THE DATA AND DETERMINED THAT THE CURE RATE DROPPED FROM 50% AFTER A MEAN FOLLOW-UP OF 13.9 MONTHS TO 21% AFTER A MEAN FOLLOW-UP OF 60 MONTHS. ALTHOUGH THE SUCCESS RATE IS NOT AS HIGH AS INITIALLY REPORTED, IT IS NOT UNEXPECTED FOR THE REPAIRS TO FAIL GIVEN THE NATURE OF ANAL FISTULAS. ALTHOUGH NO STUDIES HAVE BEEN PERFORMED TO EVALUATE THIS SPECIFIC APPLICATION, APPLICATION OF BIOGLUE TO AN AREA THAT IS CONTAMINATED AND INFLAMED IS NOT LIKELY TO RESULT IN A SUCCESSFUL OUTCOME. THE BIOGLUE INSTRUCTIONS FOR USE WARNS AGAINST USING BIOGLUE IN THE PRESENCE OF AN INFECTION AND USE WITH CAUTION IN CONTAMINATED AREAS. OF NOTE, RESOLUTION OF AN ANAL FISTULA BY ANY MEANS IS DIFFICULT TO ACHIEVE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED FOR THE TREATMENT OF HIGH TRANSSPHINCTERIC ANAL FISTULAS. AFTER A MAN FOLLOW-UP OF 13.9 MONTHS THE AUTHOR OF THIS PUBLICATION REPORTED A 50% CURE RATE. HOWEVER, AFTER A MEAN FOLLOW-UP OF 60 MONTHS THE CURE RATE DROPPED TO 21%. THE PUBLICATION STATES, "WE BELIEVE THAT THE USE OF BIOGLUE IN THE TREATMENT OF HIGH ANAL FISTULAS RESULTS IN UNACCEPTABLE HIGH RECURRENCE RATES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL GLUE MUQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other