BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3830196 · Received May 23, 2014

    Report

    Report Number
    1063481-2014-00020
    Event Type
    Injury
    Date Received
    May 23, 2014
    Report Date
    May 19, 2014
    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

    THE PATIENT HAD ACUTE AORTIC DISSECTION AND AN ASCENDING AORTA REPLACEMENT WAS PERFORMED. BIOGLUE WAS APPLIED TO THE PROXIMAL FALSE LUMEN AND PROXIMAL AND DISTAL SUTURE LINES. THE APPLIED AMOUNT IS UNKNOWN BUT THE SURGEON CONDUCTED DE-AIRING, PRIMING, AND OTHER PROCEDURES. "A WHILE AFTER SURGERY", PLEURAL EFFUSION OF UNKNOWN ORIGIN DEVELOPED AND NEGATIVE PRESSURE WOUND THERAPY WAS PERFORMED. THE PLEURAL EFFUSION DISAPPEARED AFTER THE NEGATIVE PRESSURE WOUND THERAPY WAS PERFORMED AND THE PATIENT DISCHARGED FROM THE HOSPITAL. THE PLEURAL EFFUSION WAS FOUND BY CT SCAN. THE SURGEON STATED THAT BECAUSE OF OSTEOPOROSIS, "STERNAL WIRE HAD BROKEN STERNUMS GRADUALLY AFTER THE SURGERY AND THE PLEURAL EFFUSION MIGHT HAVE OOZED FROM SMALL SPACE BETWEEN DISLOCATED STERNUMS. "WE ASKED CMI FOR CLARIFICATION ABOUT THE SURGEON'S PREVIOUS STATEMENT. THIS IS THE RESPONSE RECEIVED FROM CMI, "THE SURGEON'S IDEA IS JUST THAT THE PLEURAL EFFUSION WAS NOT INFLAMMATORY RESPONSE DUE TO BIOGLUE BUT CAUSED BY OSTEOPOROSIS. BUT THE SURGEON STATED THAT THE ABOVE IDEA LACKS EVIDENCE." A REVIEW WAS PERFORMED ON THE AVAILABLE INFORMATION. THE MANUFACTURING RECORDS WERE REVIEWED. IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD (DMR). THE MEDIASTINUM IS ANATOMICALLY SEPARATE FROM THE PLEURAL SPACE AND A FLUID COLLECTION IN THE MEDIASTINUM SHOULD NOT FLOW INTO THE PLEURAL CAVITY UNLESS THERE WAS ABNORMAL CONNECTION. LIKEWISE, THE AORTA, AND CONSEQUENTLY THE BIOGLUE USED IN THIS CASE, ARE ALSO LOCATED IN THE MEDIASTINUM AND WOULD NOT CAUSE A PLEURAL EFFUSION. THERE ARE MANY REASONS FOR A POST-OPERATIVE PLEURAL EFFUSION, NONE OF WHICH ARE RELATED TO BIOGLUE. THESE WOULD INCLUDE ATELECTASIS, PNEUMONITIS, OR VOLUME OVER LOAD. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, WE ARE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE PLEURAL EFFUSION OBSERVED IN THIS PATIENT. PLEURAL EFFUSION IS NOT A COMMONLY REPORTED ADVERSE EVENT RELATED TO THE USE OF BIOGLUE. ADDITIONAL INFORMATION WOULD BE REQUIRED TO MORE THOROUGHLY INVESTIGATE THIS COMPLAINT AND POTENTIALLY DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE IFU LISTS "PLEURAL EFFUSION, INFLAMMATORY, IMMUNE SYSTEMIC ALLERGIC REACTION AND HYPERSENSITIVITY SECTION SUCH AS SWELLING OR EDEMA AT THE APPLICATION SITE" AS POTENTIAL ADVERSE EVENTS THAT MAY OCCUR FROM THE USE OF BIOGLUE.

    Description of Event or Problem · 1

    THE PATIENT HAD ACUTE AORTIC DISSECTION AND AN ASCENDING AORTA REPLACEMENT WAS PERFORMED. BIOGLUE WAS APPLIED TO THE PROXIMAL FALSE LUMEN AND PROXIMAL AND DISTAL SUTURE LINES. THE APPLIED AMOUNT IS UNKNOWN BUT THE SURGEON CONDUCTED DE-AIRING, PRIMING, AND OTHER PROCEDURES. "A WHILE AFTER SURGERY", PLEURAL EFFUSION OF UNKNOWN ORIGIN DEVELOPED AND NEGATIVE PRESSURE WOUND THERAPY WAS PERFORMED. THE PLEURAL EFFUSION DISAPPEARED AFTER THE NEGATIVE PRESSURE WOUND THERAPY WAS PERFORMED AND THE PATIENT DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    ACCORDING TO CASE REPORT (B)(4), THE PATIENT HAD ACUTE AORTIC DISSECTION AND AN ASCENDING AORTA REPLACEMENT WAS PERFORMED. BIOGLUE WAS APPLIED TO THE PROXIMAL FALSE LUMEN AND PROXIMAL AND DISTAL SUTURE LINES. THE APPLIED AMOUNT IS UNKNOWN BUT THE SURGEON CONDUCTED DE-AIRING, PRIMING, AND OTHER PROCEDURES. "A WHILE AFTER SURGERY", PLEURAL EFFUSION OF UNKNOWN ORIGIN DEVELOPED AND NEGATIVE PRESSURE WOUND THERAPY WAS PERFORMED. THE PLEURAL EFFUSION DISAPPEARED AFTER THE NEGATIVE PRESSURE WOUND THERAPY WAS PERFORMED AND THE PATIENT DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307857 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O