BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3757117 · Received April 17, 2014

    Report

    Report Number
    1063481-2014-00016
    Event Type
    Injury
    Date Received
    April 17, 2014
    Report Date
    April 14, 2014
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUBLICATION "BLOCKAGE OF A MECHANICAL AORTIC VALVE LEAFLET WITH BIOGLUE: A CASE REPORT," A (B)(6) WOMAN UNDERWENT OPERATION FOR SYMPTOMATIC TIGHT AORTIC STENOSIS. AFTER IMPLANTATION OF AN AORTIC VALVE BECAUSE OF A TRANSVERSE TEAR OF THE AORTIC WALL ABOVE THE ANNULUS OCCURRING DURING THE SUTURING OF THE AORTOTOMY, A TRIANGULAR VASCUTEK DACRON GELSOFT PLUS PATCH WAS INCLUDED. BIOGLUE WAS APPLIED TO SECURE HEMOSTASIS. A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) EXAMINATION PERFORMED AFTER SIGNS OF ISCHEMIA APPEARS IN THE ELECTROCARDIOGRAM ON POSTOPERATIVE DAY 5 REVEALED AN AORTIC TRANSVALVULAR GRADIENT OF 74/38MM HG AND A FUNCTIONAL VALVE AREA OF 1.0 CM2. NO CORONARY LESIONS WERE REVEALED IN A CORONAROGRAPHY EVALUATION, BUT CINEFLUOROSCOPY (CF) EXAMINATION REVEALED IMMOBILITY OF ONE VALVE LEAFLET. THE REOPERATION REVEALED A THICK, ROUGH LAYER OF THE GLUE ON THE INNER SIDE OF THE PATCH. THE GLUE HAD RUN DOWN TO THE VALVE, BLOCKING A MECHANICAL LEAFLET. CLEANING THE VALVE WAS NOT POSSIBLE, AND THE VALVE HAD TO BE CHANGED. AFTER THE SECOND OPERATION, THE PATIENT WAS DISCHARGED IN A GOOD CONDITION ON POSTOPERATIVE DAY TEN. AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING INFORMATION ON THE LOT NUMBER USED, DATE OF PROCEDURE, OPERATIVE NOTES, AND CLARIFICATION ON DESCRIPTIONS USED IN THE PUBLICATION. NOTIFICATION WAS RECEIVED THAT THE SURGEON HAD RETIRED. THEREFORE, NO ADDITIONAL INFORMATION COULD BE OBTAINED. AS THE DATE OF THE INITIAL PROCEDURE COULD NOT BE ESTABLISHED AND THE LOT NUMBER OF BIOGLUE USED ON THE PATIENT COULD NOT BE DETERMINED, A MANUFACTURING REVIEW OF RECORDS COULD NOT BE PERFORMED. A REVIEW WAS PERFORMED ON THE AVAILABLE INFORMATION. THE CAUSE OF THE BIOGLUE ENTERING THE LUMEN OF THE VESSEL AND ADHERING TO THE WALL OF THE TRIANGULAR GELSOFT PLUS PATCH AND THE LEAFLET OF THE MECHANICAL AORTIC VALVE IMPLANTED INTO THE PATIENT COULD NOT BE DEFINITIVELY DETERMINED. WOVEN POLYESTER GRAFT MATERIAL, SUCH AS DACRON, IS A VERY COMMON GRAFT MATERIAL TO BE USED IN CONJUNCTION WITH BIOGLUE. IT IS UNLIKELY THAT THE BIOGLUE LEAKED THROUGH THE INTERSTICES OF THE GRAFT MATERIAL, ESPECIALLY GIVEN THE STRUCTURE OF THE DACRON GELSOFT PLUS GRAFT THAT WAS UTILIZED. ACCORDING TO THE MANUFACTURER, THE GELSOFT PLUS GRAFT IS A KÖPER KNITTED POLYESTER GRAFT THAT IS SEALED WITH GELATIN. THIS STRUCTURE IS INTENDED TO REDUCE DILATATION DUE TO THE UNIQUE KNITTING, WHICH IS "TIGHTER" THAN WARP KNITTED GRAFTS. THIS CHARACTERISTIC WOULD MAKE IT EVEN LESS LIKELY FOR BIOGLUE TO CROSS THROUGH THE INTERSTICES INTO THE LUMEN OF THE GRAFT. IN THIS CASE, THE SURGEON CUT A TRIANGULAR PATCH FROM A GELSOFT PLUS GRAFT AND SUTURED IT INTO PLACE TO REPAIR A TRANSVERSE TEAR IN THE AORTIC WALL ABOVE THE ANNULUS THAT OCCURRED DURING SUTURING OF THE AORTOTOMY. IT IS POSSIBLE THAT BIOGLUE LEAKED THROUGH AT THE SUTURE LINE, THE POTENTIAL CAUSES OF WHICH INCLUDE, BUT ARE NOT LIMITED TO BIOGLUE ENTERING THE LUMEN THROUGH A GAP IN THE SUTURE LINE OR BIOGLUE ENTERING THE LUMEN DUE TO APPLICATION WITH THE CARDIAC VENTS ON. IT IS KNOWN THAT IS BIOGLUE COMES IN CONTACT WITH VALVE LEAFLETS THIS COULD RESULT IN VALVE DYSFUNCTION. APPROPRIATE PRECAUTIONS AND WARNINGS ARE INCLUDED IN THE INSTRUCTIONS FOR USE (IFU). SINCE DACRON IS INTENDED TO MAINTAIN INTEGRITY OF THE VASCULAR SYSTEM AND PREVENT LEAKAGE OF SERUM PROTEINS OUT OF THE CIRCULATION, IT IS LOGICAL TO CONCLUDE THAT PROTEIN SOLUTIONS ARE UNLIKELY TO PASS THROUGH THE MATERIAL WHEN APPLIED TO THE EXTERNAL SURFACE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION "BLOCKAGE OF A MECHANICAL AORTIC VALVE LEAFLET WITH BIOGLUE: A CASE REPORT," A (B)(6) WOMAN UNDERWENT OPERATION FOR SYMPTOMATIC TIGHT AORTIC STENOSIS. AFTER IMPLANTATION OF AN AORTIC VALVE BECAUSE OF A TRANSVERSE TEAR OF THE AORTIC WALL ABOVE THE ANNULUS OCCURRING DURING THE SUTURING OF THE AORTOTOMY, A TRIANGULAR VASCUTEK DACRON PATCH WAS INCLUDED. BIOGLUE WAS APPLIED TO SECURE HEMOSTASIS. A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) EXAMINATION PERFORMED AFTER SIGNS OF ISCHEMIA APPEARS IN THE ELECTROCARDIOGRAM ON POSTOPERATIVE DAY 5 REVEALED AN AORTIC TRANSVALVULAR GRADIENT OF 74/38MM HG AND A FUNCTIONAL VALVE AREA OF 1.0 CM2. NO CORONARY LESIONS WERE REVEALED IN A CORONAROGRAPHY EVALUATION, BUT CINEFLUOROSCOPY (CF) EXAMINATION REVEALED IMMOBILITY OF ONE VALVE LEAFLET. THE REOPERATION REVEALED A THICK, ROUGH LAYER OF THE GLUE ON THE INNER SIDE OF THE PATCH. THE GLUE HAD RUN DOWN TO THE VALVE, BLOCKING A MECHANICAL LEAFLET. CLEANING THE VALVE WAS NOT POSSIBLE, AND THE VALVE HAD TO BE CHANGED.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION "BLOCKAGE OF A MECHANICAL AORTIC VALVE LEAFLET WITH BIOGLUE: A CASE REPORT," A (B)(6) OLD WOMAN UNDERWENT OPERATION FOR SYMPTOMATIC TIGHT AORTIC STENOSIS. AFTER IMPLANTATION OF AN AORTIC VALVE BECAUSE OF A TRANSVERSE TEAR OF THE AORTIC WALL ABOVE THE ANNULUS OCCURRING DURING THE SUTURING OF THE AORTOTOMY, A TRIANGULAR VASCUTEK DACRON PATCH WAS INCLUDED. BIOGLUE WAS APPLIED TO SECURE HEMOSTASIS. A TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) EXAMINATION PERFORMED AFTER SIGNS OF ISCHEMIA APPEARS IN THE ELECTROCARDIOGRAM ON POSTOPERATIVE DAY 5 REVEALED AN AORTIC TRANSVALVULAR GRADIENT OF 74/38MM HG AND A FUNCTIONAL VALVE AREA OF 1.0 CM2. NO CORONARY LESIONS WERE REVEALED IN A CORONAROGRAPHY EVALUATION, BUT CINEFLUOROSCOPY (CF) EXAMINATION REVEALED IMMOBILITY OF ONE VALVE LEAFLET. THE REOPERATION REVEALED A THICK, ROUGH LAYER OF THE GLUE ON THE INNER SIDE OF THE PATCH. THE GLUE HAD RUN DOWN TO THE VALVE, BLOCKING A MECHANICAL LEAFLET. CLEANING THE VALVE WAS NOT POSSIBLE, AND THE VALVE HAD TO BE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234174 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other