BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 5073800 · Received September 14, 2015

    Report

    Report Number
    1063481-2015-00218
    Event Type
    Injury
    Date Received
    September 14, 2015
    Report Date
    August 18, 2015
    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

    ACCORDING TO THE REPORT, THE FOLLOWING STATEMENT WAS EMBEDDED IN A COMMUNICATION FROM (B)(6) : "DURING (B)(6) SOCIETY OF VASCULAR SURGERY (JSVS) MEETING, WE HEARD A NEGATIVE PRESENTATION OF BIOGLUE, WHICH MENTIONED FORMATION OF FALSE ANEURYSM AFTER USING BIOGLUE. ACCORDING TO THE PROVIDED ABSTRACT, BETWEEN JANUARY 2009 AND AUGUST 2014, 7 THORACIC AORTIC OPEN SURGERY CASES OF 5 PATIENTS AMONG 169 CASES WERE INVESTIGATED. "WHEN THE FIRST SURGERIES WERE OPERATED, BIOGLUE WAS USED FOR STUMP FORMING AND ANASTOMOSIS. THE PARTS WHERE FALSE ANEURYSM WERE RECOGNIZED, WERE 2 CASES IN THE REGION OF ORIGIN OF BRACHIOCEPHALIC ARTERY, 2 CASES IN THE LEFT VENTRICULAR OUTFLOW TRACT, 2 CASES IN THE AORTIC ROOT, 1 CASE IN THE AORTIC ROOT AND ARCH. FOR ALL CASES, THERE WAS NO SIGN OF INFECTION." THIS REPORT REPRESENTS THE THIRD OF SEVEN EVENTS. THE FOLLOWING TRANSLATION OF THE (B)(6) ABSTRACT WAS PROVIDED: "IN (B)(6) HOSPITAL ADVANCED CARE CENTER, RECENTLY WE EXPERIENCED SOME POSTOPERATIVE FALSE ANEURYSM CASE. OUR PURPOSE IS TO EXAMINE PATIENT CHARACTERISTICS AND SURGERY DATA TO INVESTIGATE THE CASE OF THIS PROBLEM. BETWEEN JAN. 2009 AND AUG. 2014, 7 THORACIC AORTIC OPEN SURGERY CASES OF 5 PATIENTS AMONG 169 CASES WERE INVESTIGATED. 4 MALES AND 1 FEMALE. AS A SUBJECTIVE SYMPTOM, THERE WERE 4 CASES OF SUBCUTANEOUS MASS, 2 CASES OF FEVER, AND 1 CASE OF BACKACHE. THE TERM LENGTH BETWEEN THE 1ST SURGERY (WHICH MEANS THE SURGERY PROBABLY CAUSING THE FALSE ANEURYSM) AND THE RECOGNITION OF THE FALSE ANEURYSM IS 9.9 MONTHS (2.5 - 14.5 MONTHS). REGARDING 3 PATIENTS, THEY UNDERWENT OPEN SURGERY BEFORE THE 1ST SURGERY (WHICH MEANS THE SURGERY PROBABLY CAUSING THE FALSE ANEURYSM). REGARDING THE 1ST SURGERY, 3 CASES WERE HEMIARCH REPAIR, 2 CASES WERE AORTIC ROOT REPLACEMENT, 1 CASE WAS HEMIARCH REPAIR AND AORTIC ROOT REPLACEMENT, AND 1 CASE WAS THE HEMIARCH REPAIR, AORTIC ROOT REPLACEMENT AND MAP. WHEN THE 1ST SURGERIES WERE OPERATED, BIOGLUE WAS USED FOR STUMP FORMING AND ANASTOMOSIS. THE PARTS WHERE FALSE ANEURYSM WERE RECOGNIZED, WERE 2 CASES IN THE REGION OF ORIGIN OF BRACHIOCEPHALIC ARTERY, 2 CASES IN THE LEFT VENTRICULAR OUTFLOW TRACE, 2 CASES IN THE AORTIC ROOT, 1 CASE IN THE AORTIC ROOT AND ARCH. FOR ALL CASES, THERE WAS NO SIGN OF INFECTION. THE 6 CASES WERE REOPERATED FOR FALSE ANEURYSMS. 1 CASE WAS BY TEVAR [THORACIC ENDOVASCULAR AORTIC REPAIR], AND REMAINING 5 CASES WERE BY OPEN SURGERY. INTRAOPERATIVE FINDING OF 5 CASES FALSE ANEURYSMS WERE (1) 1 CASE OF THE ANASTOMOSIS BETWEEN THE ARTIFICIAL GRAFT AND THE AORTIC ARCH (CONTINUOUS SUTURE), (2) 1 CASE OF THE ANASTOMOSIS BETWEEN THE AORTIC ANNULUS AND THE FREESTYLE VALVE, (3) 2 CASES OF THE LEFT VENTRICULAR OUTFLOW TRACT JUST UNDER THE NON-CORONARY CUSP, (4) 1 CASE AROUND THE ST [SINOTUBULAR] JUNCTION OF THE AORTIC ROOT IN THE AORTIC DISSECTION. FOR CASE (1), THE VASCULAR PROSTHESIS IMPLANTATION WAS OPERATED AGAIN. FOR CASE (2), THE ROOT REPLACEMENT WAS OPERATED WITH HOMOGRAFT. FOR CASE (3), THE PATCH WAS ATTACHED TO THE RAPTURE PART. FOR CASE (4), THE ROOT REPLACEMENT WAS OPERATED. WE LOST 2 PATIENTS ACCORDING TO BLEEDING. FALSE ANEURYSM CASES WERE RECOGNIZED FOR REOPERATION CASES. WE USED BIOGLUE FROM (B)(6) 2011, AND WE MAINLY APPLIED IT TO THE ANASTOMOSIS AND THE STUMP FORMING OF THE DISSECTION CASES FOR SUPPORTING HEMOSTASIS. WE CONSIDER THAT IT IS SAFE TO USE BIOGLUE AS HEMOSTASIS PURPOSE SINCE IT IS NORMAL USAGE IN FOREIGN COUNTRIES. HOWEVER FOR ALL THESE 7 CASES, BIOGLUE WERE USED. SO, WE CONSIDER THAT THERE MAY BE BOTH THE INFLUENCE OF BIOGLUE ON THE FALSE ANEURYSM FORMING, AND OUR INCORRECT USAGE AND BIOGLUE APPLICATION TECHNIQUE." A REVIEW OF MANUFACTURING RECORDS WAS NOT PERFORMED AS LOT NUMBERS FOR THE BIOGLUE DEVICES ARE UNKNOWN AND WERE NOT PROVIDED BY THE DISTRIBUTOR. A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. FIVE PATIENTS UNDERWENT 7 OPEN THORACIC AORTIC PROCEDURES IN WHICH BIOGLUE WAS USED. SIX REOPERATIONS [1 THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) AND 5 OPEN PROCEDURES] FOR FALSE ANEURYSM WERE PERFORMED. TWO PATIENTS DIED DUE TO BLEEDING. MEAN TIME BETWEEN ORIGINAL SURGERY AND RECOGNITION OF FALSE ANEURYSM WAS 9.9 MONTHS (RANGE, 2.5-14.5 MONTHS). NO INFECTION WAS REPORTED FOR ANY CASE. THE EXPECTED OUTCOME IS SUCCESSFUL REPAIR OF AORTIC DISSECTION. THE SURGICAL TECHNIQUES/TREATMENT USED IN THESE EVENTS WAS REOPERATION FOR FALSE ANEURYSM (INCLUDING, BUT NOT LIMITED TO, TEVAR, AORTIC ROOT REPLACEMENT WITH HOMOGRAFT, AND PATCH REPAIR). THE AUTHORS STATE THAT BIOGLUE MAY HAVE CONTRIBUTED TO FALSE ANEURYSM FORMATION. THEY ALSO STATE THAT THEIR INCORRECT USAGE AND BIOGLUE APPLICATION TECHNIQUE MAY HAVE ALSO CONTRIBUTED. THE ROOT CAUSE FOR THE REPORTED EVENTS IS UNKNOWN. THE IFU ADEQUATELY COMMUNICATES RISK. CORRECTIVE ACTION WAS PREVIOUSLY INITIATED FOR PSEUDOANEURYSM EVENTS REPORTED FROM (B)(6). THE CASES REPORTED HERE OCCURRED BEFORE CORRECTIVE ACTION WAS INITIATED.

    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 REPORT, THE FOLLOWING STATEMENT WAS EMBEDDED IN A COMMUNICATION FROM (B)(6) : "DURING (B)(6) SOCIETY OF VASCULAR SURGERY (JSVS) MEETING, WE HEARD A NEGATIVE PRESENTATION OF BIOGLUE, WHICH MENTIONED FORMATION OF FALSE ANEURYSM AFTER USING BIOGLUE. ACCORDING TO THE PROVIDED ABSTRACT, BETWEEN JANUARY 2009 AND AUGUST 2014, 7 THORACIC AORTIC OPEN SURGERY CASES OF 5 PATIENTS AMONG 169 CASES WERE INVESTIGATED. "WHEN THE FIRST SURGERIES WERE OPERATED, BIOGLUE WAS USED FOR STUMP FORMING AND ANASTOMOSIS. THE PARTS WHERE FALSE ANEURYSM WERE RECOGNIZED, WERE 2 CASES IN THE REGION OF ORIGIN OF BRACHIOCEPHALIC ARTERY, 2 CASES IN THE LEFT VENTRICULAR OUTFLOW TRACT, 2 CASES IN THE AORTIC ROOT, 1 CASE IN THE AORTIC ROOT AND ARCH. FOR ALL CASES, THERE WAS NO SIGN OF INFECTION." THIS REPORT REPRESENTS THE THIRD OF SEVEN EVENTS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE FOLLOWING STATEMENT WAS EMBEDDED IN A COMMUNICATION FROM (B)(6): "DURING (B)(6) MEETING, WE HEARD A NEGATIVE PRESENTATION OF BIOGLUE, WHICH MENTIONED FORMATION OF FALSE ANEURYSM AFTER USING BIOGLUE. ACCORDING TO THE PROVIDED ABSTRACT, BETWEEN JANUARY 2009 AND AUGUST 2014, 7 THORACIC AORTIC OPEN SURGERY CASES OF 5 PATIENTS AMONG 169 CASES WERE INVESTIGATED. "WHEN THE FIRST SURGERIES WERE OPERATED, BIOGLUE WAS USED FOR STUMP FORMING AND ANASTOMOSIS. THE PARTS WHERE FALSE ANEURYSM WERE RECOGNIZED, WERE 2 CASES IN THE REGION OF ORIGIN OF BRACHIOCEPHALIC ARTERY, 2 CASES IN THE LEFT VENTRICULAR OUTFLOW TRACT, 2 CASES IN THE AORTIC ROOT, 1 CASE IN THE AORTIC ROOT AND ARCH. FOR ALL CASES, THERE WAS NO SIGN OF INFECTION." THIS REPORT REPRESENTS THE THIRD OF SEVEN EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606418 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other