BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2900392 · Received January 7, 2013

    Report

    Report Number
    1063481-2013-00001
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    July 19, 2013
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER WAS THE DISTRIBUTOR OF THE DEVICE, (B)(6). THE SURGEON WHO USED THE DEVICE IS DR. (B)(6). THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED FOR OBLITERATION OF PROXIMAL FALSE LUMEN IN A TOTAL ARCH REPLACEMENT OPERATION FOR ACUTE AORTIC DISSECTION IN (B)(6) 2012. AFTER APPROXIMATELY FIVE MONTHS LATER, ECHOCARDIOGRAM WAS PERFORMED AND RECANALIZATION WAS FOUND AT THE PROXIMAL ANASTOMOSIS SITE WHERE BIOGLUE WAS APPLIED. IT WAS FOUND THAT BIOGLUE HAD BEEN PEELED FROM THE TISSUE AND AORTIC DISSECTION OCCURRED. THEREFORE, AN INVESTIGATION WAS PERFORMED. A REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL PHYSICAL, FUNCTIONAL, MICROBIAL AND CHEMICAL SPECIFICATIONS PER THE DEVICE MASTER RECORDS. BIOGLUE WORKS THROUGH FORMING COVALENT BONDS WITH THE TISSUE. WHEN USING BIOGLUE IN AORTIC DISSECTION SURGERY, IT IS IMPORTANT TO CLEAR THE DISSECTED LAYERS FROM BLOOD AND THROMBUS MATERIAL AND DRY WITH SURGICAL SPONGES. LACK OF PROPER SITE PREPARATION CAN RESULT IN THE PRESENCE OF RESIDUAL THROMBUS OR DEBRIS AT THE TARGET APPLICATION SITE, WHICH WILL RESULT IN THE ADHERENCE OF BIOGLUE TO THESE OTHER MATERIALS VERSUS THE TARGETED TISSUES. THIS CAN PRODUCE A COMPROMISED REPAIR SITE AND POSSIBLE REDISSECTION. IT IS ALSO POSSIBLE THAT THE DELIVERY DEVICE WAS NOT PRIMED PROPERLY PRIOR TO APPLICATION, WHICH COULD RESULT IN THE DELIVERY OF MATERIAL THAT DOES NOT CONTAIN THE APPROPRIATE RATIOS OF THE BIOGLUE COMPONENTS. THIS CAN COMPROMISE THE STRENGTH OF THE PRODUCT AND LEAD TO REDISSECTION. IT IS ALSO POSSIBLE THAT THE PRODUCT WAS APPLIED IN A PROPERLY PREPARED FIELD BUT ON COMPROMISED NATIVE TISSUE, IN WHICH REDISSECTION OCCURRED DUE TO THE POOR STATE OF THE NATIVE TISSUE. WITH THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE BIOGLUE INSTRUCTIONS FOR USE (IFU) ADDRESS PREPARATION OF THE TARGET APPLICATION, DEVICE PRIMING, AND THE DISEASE STATE OF THE NATIVE TISSUE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED FOR OBLITERATION OF THE PROXIMAL FALSE LUMEN IN A TOTAL ARCH REPLACEMENT OPERATION FOR ACUTE AORTIC DISSECTION. THE SURGERY OCCURRED IN (B)(6) 2012. APPROXIMATELY FIVE MONTHS LATER, AN ECHOCARDIOGRAM REVEALED THAT BIOGLUE WAS PEELING FROM THE PROXIMAL ANASTOMOSIS SITE AND RECANALIZATION HAD OCCURRED. THE PATIENT IS BEING SEEN AT THE HOSPITAL FOR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6576 BIOGLUE SURGICAL ADHESIVE SURGICAL GLUE MUQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R