BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3731106 · Received April 7, 2014

    Report

    Report Number
    1063481-2014-00012
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    November 8, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS PREVIOUSLY CLOSED. THE ORIGINAL INVESTIGATOR DID NOT BELIEVE THE EVENT MET FEDERAL REPORTING REQUIREMENTS. THE INVESTIGATION WAS REOPENED ON (B)(4) 2014 TO RE-EVALUATE ADDITIONAL INFORMATION. AT THE TIME OF REOPENING, IT WAS DETERMINED THAT THIS EVENT WAS REPORTABLE. THIS REPORT IS BEING SUBMITTED AS A RESULT. ACCORDING TO THE REPORT, BIOGLUE WAS USED FOR THE OBLITERATION OF THE PROXIMAL FALSE LUMEN IN A STANDARD TYPE A ACUTE AORTIC DISSECTION. WHEN SHIFTING TREATMENT TO THE DISTAL FALSE LUMEN, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED FALSE ANEURYSM IN THE PROXIMAL AORTA TO WHICH BIOGLUE WAS APPLIED. SUBSEQUENTLY, THE SURGEON CONFIRMED THAT "BIOGLUE HAD BEEN PEELED FROM TISSUE." THE SURGEON ASSUMES THAT THE FALSE ANEURYSM WAS DUE TO STITCHING A VASCULAR GRAFT ONTO NATIVE AORTA. SINCE THE SIZE OF THE VASCULAR GRAFT (35MM) DIFFERED FROM THE SIZE OF THE NATIVE AORTA (28MM), THE SURGEON DENSELY STITCHED THE VASCULAR GRAFT ONTO NATIVE AORTA. HE BELIEVES THAT THE INTIMA OF A BLOOD VESSEL WAS RUPTURED AND CAUSED THE FALSE ANEURYSM. THE EVENT OCCURRED AND WAS IMMEDIATELY TREATED DURING THE INITIAL OPERATION. THE SURGEON ACKNOWLEDGED A SIGNIFICANT DIFFERENCE IN SIZE BETWEEN THE NATIVE AORTA AND THE VASCULAR GRAFT. THE REASON FOR THE MISMATCHED SIZE IS UNKNOWN. A DENSELY SUTURED ANASTOMOTIC SITE, SUCH AS THE REPORT DESCRIPTION, WOULD LIKELY PRODUCE SIGNIFICANT TISSUE DISTORTION AND PLACE TENSION ON THE NATIVE AORTA WHICH WOULD CAUSE ENLARGEMENT OF THE SUTURE HOLES ON THE INTIMAL SURFACE AND CREATE A PATHWAY FOR BLOOD TO FLOW THROUGH. AS SUCH, CRYOLIFE CONCURS WITH THE SURGEON'S VIEW THAT "THE CAUSE OF THE FALSE ANEURYSM WAS DUE TO STITCHING" AND THAT BIOGLUE WAS NOT RELATED TO THE FORMATION OF THE FALSE ANEURYSM. THE EXACT LOCATION OF PEELED BIOGLUE WAS NOT SPECIFIED. THERE WAS NO RECURRENCE OF DISSECTION NOTED, AS WOULD BE EXPECTED IF THE BIOGLUE FAILED TO ADHERE IN THE FALSE LUMEN UPON APPLICATION. THEREFORE, IT IS ASSUMED THAT THE SURGEON PLACED BIOGLUE OVER THE SUTURES ON THE OUTSIDE OF THE ORIGINAL ANASTOMOSIS AND IT PEELED OFF FROM THIS LOCATION. THE SURFACE WOULD BE VERY IRREGULAR AND UNEVEN, AND THE FALSE ANEURYSM THAT FORMED MAY HAVE FORCED BIOGLUE TO BE PUSHED AWAY. INCREASED SUTURE DENSITY AT THE ANASTOMOSIS MAY HAVE PREVENTED PROPER ADHERENCE OF BIOGLUE. IT IS POSSIBLE THAT EITHER THE PRESENCE OF THROMBUS MATERIAL/DEBRIS IN THE FALSE LUMEN AND/OR THE COMMENCEMENT OF SUTURING PRIOR TO COMPLETE PRODUCT POLYMERIZATION COULD HAVE CAUSED BIOGLUE TO BE "PEELED" FROM TISSUE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE OF THE FALSE ANEURYSM AND PEELING OF THE BIOGLUE CANNOT BE MADE. IT IS POSSIBLE THAT THE REPORTED EVENT MAY HAVE BEEN DUE TO THE SIZE MISMATCH OF THE VASCULAR GRAFT AND NATIVE TISSUE. THE MANUFACTURING RECORDS FOR ALL POSSIBLE LOTS WERE REVIEWED. ALL LOTS MET ALL FINAL RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED FOR THE OBLITERATION OF THE PROXIMAL FALSE LUMEN IN A STANDARD TYPE A ACUTE AORTIC DISSECTION. WHEN SHIFTING TREATMENT TO THE DISTAL FALSE LUMEN, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED FALSE ANEURYSM IN THE PROXIMAL AORTA TO WHICH BIOGLUE WAS APPLIED. SUBSEQUENTLY, THE SURGEON CONFIRMED THAT "BIOGLUE HAD BEEN PEELED FROM TISSUE." THE SURGEON ASSUMES THAT THE FALSE ANEURYSM WAS DUE TO STITCHING A VASCULAR GRAFT ONTO NATIVE AORTA. SINCE THE SIZE OF THE VASCULAR GRAFT (35MM) DIFFERED FROM THE SIZE OF THE NATIVE AORTA (28MM), THE SURGEON DENSELY STITCHED THE VASCULAR GRAFT ONTO NATIVE AORTA. HE BELIEVES THAT THE INTIMA OF A BLOOD VESSEL WAS RUPTURED AND CAUSED THE FALSE ANEURYSM. THE EVENT OCCURRED AND WAS IMMEDIATELY TREATED DURING THE INITIAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207829 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other