BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 7125465 · Received December 18, 2017

    Report

    Report Number
    1063481-2017-00041
    Event Type
    Death
    Date Received
    December 18, 2017
    Report Date
    March 12, 2018
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ATTEMPTS WERE MADE VIA THE DISTRIBUTOR TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, "WE HAVE MADE SEVERAL ATTEMPTS, BUT NO ADDITIONAL INFORMATION ON TREATMENTS GIVEN TO THE PATIENT COULD HAVE BEEN OBTAINED." A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. THE PATIENT UNDERWENT A VENTRICULAR SEPTAL PERFORATION ON AN UNKNOWN DATE. BIOGLUE WAS APPLIED TO ABOUT 20% OF THE EPICARDIUM DURING THE REPAIR. AFTER THE SURGERY, THE PATIENT HAD AN ELEVATED C-REACTIVE PROTEIN (CRP) AND WHITE CELL BLOOD CELL COUNT (WBC) FOR A FEW WEEKS. AT AN UNSPECIFIED AMOUNT OF TIME LATER THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. ACCORDING TO THE DISTRIBUTOR, "WE HAVE MADE SEVERAL ATTEMPTS, BUT NO ADDITIONAL INFORMATION ON TREATMENTS GIVEN TO THE PATIENT COULD HAVE BEEN OBTAINED. DOCTOR SAYS HE CANNOT DENY THE POSSIBILITY THIS INFLAMMATION IS ATTRIBUTED TO THE USE OF BIOGLUE. WE JUST OBTAINED HIS COMMENT WITHOUT ANY INFORMATION WHAT LED HIM THINK SO. JUST SO THAT YOU KNOW, WE HAVE INFORMED THIS DOCTOR AGAIN ABOUT THE PROPER AMOUNT OF USE." IT IS UNKNOWN THE AMOUNT OF BIOGLUE USED, IF OTHER MATERIALS WERE USED (PATCH OR SUTURES), WHAT PART OF THE EPICARDIUM WAS BIOGLUE APPLIED TO. ADDITIONAL UNKNOWN INFORMATION INCLUDES THE CAUSE OF DEATH, HOW LONG AFTER THE SURGERY THE PATIENT DIED, IF THERE WERE ANY POST-OPERATIVE INFECTIONS, AND IF ANY CARDIAC COMPLICATIONS WERE NOTED. THERE HAVE BEEN PREVIOUS REPORTS OF BIOGLUE BEING USED ON THE EPICARDIUM. SAXENA ET AL PUBLISHED A CASE REPORT WHERE THE PATIENT UNDERWENT OPERATIVE REPAIR OF VENTRICULAR SEPTAL DEFECT. THE CASE REPORT DESCRIBES THAT DURING THE REPAIR OF THE VENTRICULOTOMY A LARGE BOVINE PERICARDIAL PATCH WAS USED AND BIOGLUE WAS INJECTED BETWEEN THE EPICARDIUM AND THE PATCH PRIOR TO TYING SUTURES OVER THE PATCH, THEN A LAYER OF BIOGLUE WAS INFECTED AROUND THE PATCH (SAXENA 2016). ALAMANNI ET AL PUBLISHED A TECHNIQUE WHERE BIOGLUE IS USED TO SEAL A PATCH TO THE EPICARDIUM (ALAMANNI 2001). RELATED TO PUTTING BIOGLUE ON APPROXIMATELY 20% OF THE EPICARDIUM, THERE IS NO DATA TO SUPPORT WHAT IS AN APPROPRIATE AMOUNT TO USE IN THIS INDICATION. THE IFU PROVIDES THE FOLLOWING INFORMATION: ¿BIOGLUE IS NOT FOR PATIENTS WITH KNOWN SENSITIVITY TO MATERIALS OF BOVINE ORIGIN,¿ ¿EXERCISE CAUTION WITH REPEAT EXPOSURE OF BIOGLUE IN THE SAME PATIENT. HYPERSENSITIVITY REACTIONS ARE POSSIBLE UPON EXPOSURE TO BIOGLUE. SENSITIZATION HAS BEEN OBSERVED IN ANIMALS,¿ AND ¿FOR VESSEL REPAIR APPLY AN EVEN ADHESIVE COATING 1.2-3.0MM THICK FOR ANASTOMOSIS OF VESSELS/GRAFTS GREATER THAN 2.5CM IN DIAMETER; APPLY AN EVEN ADHESIVE COATING 0.5-1.0MM FOR VESSELS/GRAFTS LESS THAN 2.5CM IN DIAMETER.¿ THE IFU IDENTIFIES THE FOLLOWING POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH THE USE OF BIOGLUE: INFLAMMATORY AND IMMUNE RESPONSE, AND DEATH. THE ELEVATED C REACTIVE PROTEIN AND WBC COUNT ARE NON-SPECIFIC INDICATORS OF INFLAMMATION. FOREIGN BODY REACTIONS HAVE BEEN REPORTED WITH THE USE OF BIOGLUE. HEWITT ET AL. PERFORMED AN ANIMAL STUDY WHERE BIOGLUE WAS APPLIED TO A SHEEP¿S AORTA; HISTOPATHOLOGICALLY, BIOGLUE GENERATE ONLY A MINIMAL INFLAMMATORY RESPONSE (HEWITT ET AL 2011). WHEN USED PROPERLY, HISTOPATHOLOGICAL OBSERVATIONS WITH BIOGLUE ARE CONSISTENT WITH A NORMAL FOREIGN BODY REACTION. COSELLI ET AL. FOUND 2.6% OF BIOGLUE PATIENTS DEVELOPED INFLAMMATORY, IMMUNE SYSTEMIC ALLERGIC REACTION (COSELLI 2003). THE EXACT AMOUNT OF BIOGLUE USED IS UNKNOWN; HOWEVER, IF BOTH 10ML SYRINGES WERE USED THEN A LARGE AMOUNT WAS UTILIZED IT COULD RESULT IN AN ENHANCED OR PROLONGED INFLAMMATORY REACTION. DEATH IS A POTENTIAL ADVERSE EVENT RELATED TO CARDIAC AND VASCULAR PROCEDURES. IN 1998 CRYOLIFE BEGAN A CLINICAL TRIAL INVESTIGATING THE USE OF BIOGLUE AS AN ADJUNCT IN THE SURGICAL REPAIR OF ACUTE, STANFORD TYPE A AORTIC DISSECTIONS. A TOTAL OF 175 PATIENTS WERE ENROLLED IN THIS STUDY. THIS INCLUDED 54 NON-RANDOMIZED (LEAD-IN) PATIENTS, 60 PATIENTS RANDOMIZED TO STANDARD SURGERY PLUS BIOGLUE, AND 61 PATIENTS RANDOMIZED TO STANDARD SURGERY ONLY. AN INTERIM ANALYSIS WAS PERFORMED AFTER THE 100TH PATIENT WAS ENROLLED INTO THE RANDOMIZED PORTION OF THE TRIAL AND HAD COMPLETED THE 30-DAY FOLLOW-UP PERIOD. THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN EARLY MORTALITY BETWEEN THE TWO GROUPS (BIOGLUE SUMMARY OF SAFETY AND EFFECTIVENESS). A PROSPECTIVE RANDOMIZED CONTROL TRIAL BETWEEN BIOGLUE AND STANDARD SURGICAL REPAIR FOR ANASTOMOTIC SEALING SHOWED NO DIFFERENCE IN RATES OF DEATH BETWEEN THE BIOGLUE AND CONTROL GROUPS (COSELLI ET AL. 2003). THE CAUSE OF DEATH IS UNKNOWN. THE ELEVATED CRP AND WBC COUNT SUGGEST INFLAMMATION HOWEVER THE CAUSE OF THE INFLAMMATION CANNOT BE DETERMINED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, "THE DOCTOR USED BIOGLUE FOR THE VENTRICULAR SEPTAL PERFORATION (VSP) PATIENT AND BIOGLUE WAS USED TO EPICARDIUM. (BIOGLUE WAS USED ABOUT THE 20% OF EPICARDIUM AREA) AFTER THE SURGERY, THE PATIENT HAD BEEN SEEN HIGH RATE OF C-REACTIVE PROTEIN (CRP) AND WHITE CELL BLOOD CELL COUNT (WBC) FOR A FEW WEEKS, AND THEN THE PATIENT PASSED AWAY."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, "THE DOCTOR USED BIOGLUE FOR THE VENTRICULAR SEPTAL PERFORATION (VSP) PATIENT AND BIOGLUE WAS USED TO EPICARDIUM. (BIOGLUE WAS USED ABOUT THE 20% OF EPICARDIUM AREA) AFTER THE SURGERY, THE PATIENT HAD BEEN SEEN HIGH RATE OF C-REACTIVE PROTEIN (CRP) AND WHITE CELL BLOOD CELL COUNT (WBC) FOR A FEW WEEKS, AND THEN THE PATIENT PASSED AWAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903729 BIOGLUE SURGICAL ADHESIVE GLUE,SURGICAL,ARTERIES MUQ CRYOLIFE, INC. BG3510-5-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death