BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3883277 · Received June 19, 2014

    Report

    Report Number
    1063481-2014-00025
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 16, 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

    BIOGLUE WAS APPLIED IN PROXIMAL AND DISTAL FALSE LUMEN AND SUTURE LINES IN A PATIENT WITH AORTIC DISSECTION IN (B)(6) 2014. ON (B)(6) 2014, CT SHOWED FALSE ANEURYSM IN DISTAL ASCENDING AORTA, THEN EMERGENCY OPERATION WAS PERFORMED. ANOTHER FALSE ANEURYSM WAS FOUND IN PROXIMAL ASCENDING AORTA DURING THE OPERATION. THE FALSE ANEURYSM WAS BETWEEN RIGHT CORONARY CUSP AND LEFT CORONARY CUSP (CLOSER TO THE RIGHT CORONARY CUSP). BENTALL AND HEMIARCH AORTIC REPLACEMENT WERE PERFORMED IN THE RE-OPERATION. AT THE RE-OPERATION, IT WAS FOUND THAT BIOGLUE WHICH HAD BEEN USED IN THE INITIAL OPERATION DID NOT ADHERE WITH THE TISSUE. PUMP OXYGENATOR WAS USED FOR 12 HOURS IN THE OPERATION. AFTER THE SURGERY, PCPS AND IABP (INTRA-AORTIC BALLOON PUMPING) WERE USED IN ICU, HOWEVER THE PATIENT DIED EIGHT HOURS AFTER BEING TRANSPORTED TO THE ICU. ADDITIONAL INFORMATION WAS OBTAINED FROM THE SURGEON THAT THE APPLICATION SITE WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND THE AMOUNT OF THE APPLIED BIOGLUE WAS A PROPER QUANTITY (TWO SYRINGES). AT THE TIME OF APPLICATION DURING THE INITIAL PROCEDURE, BIOGLUE WAS ADHERING TO THE TISSUE. THE FALSE ANEURYSM WAS FOUND ON AN AREA WHERE BIOGLUE WAS NOT APPLIED DURING THE INITIAL PROCEDURE. POSSIBLE LOT NUMBERS WERE DETERMINED FROM SHIPPING RECORDS AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE CAUSE OF THE PSEUDOANEURYSMS OBSERVED IN THIS PATIENT COULD NOT DEFINITIVELY BE DETERMINED. THE SURGEON INDICATED THAT THE FALSE ANEURYSM OCCURRED IN A LOCATION IN WHICH BIOGLUE WAS NOT APPLIED; THEREFORE IT IS UNLIKELY THAT BIOGLUE CAUSED OR CONTRIBUTED TO THE FALSE ANEURYSM FORMATIONS. THE SURGEON ALSO STATED THAT THE BIOGLUE ADHERED TO THE TISSUE DURING APPLICATION BUT THAT UPON REOPERATION THE BIOGLUE THAT HAD BEEN USED IN THE PRIMARY PROCEDURE DID NOT ADHERE WITH THE TISSUE. IT IS UNCLEAR IF THE SURGEON IS REFERRING TO THE BIOGLUE DELIVERED INTO THE FALSE LUMEN, THE BIOGLUE APPLIED TO THE ANASTOMOSES, OR BOTH; HOWEVER, UNLESS THE APPLICATION SITES WERE NOT PROPERLY PREPARED (I.E., CLEARED OF ANY THROMBUS AND/OR DEBRIS AND A TEMPORARY DRY FIELD OBTAINED) BIOGLUE WOULD REMAIN ADHERED TO THE TISSUE AS THE STRENGTH OF THE COVALENT BONDING WOULD PREVENT BIOGLUE FROM PASSIVELY BECOMING NON-ADHERED (BIOGLUE MUST BE TRIMMED AWAY WITH SCISSORS ONCE ADHERED TO TISSUE). IF THE BIOGLUE WAS TRULY NOT ADHERED UPON REOPERATION, THE BIOGLUE WOULD NOT HAVE BEEN FULLY ADHERED AT APPLICATION WHICH WOULD INDICATE THAT THE SITE WAS NOT PROPERLY PREPARED PRIOR TO APPLICATION. THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF DEATH IN THIS PATIENT OR WHETHER OR NOT BIOGLUE CONTRIBUTED TO THE PATIENT'S DEATH. PSEUDOANEURYSM IS A KNOWN POTENTIAL COMPLICATION TO AORTIC DISSECTION REPAIR. ADEQUATE PRECAUTIONS ARE PROVIDED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED PRIMING OF THE BIOGLUE SYRINGE WAS PERFORMED, BUT IT MIGHT BE INSUFFICIENT. BIOGLUE WAS APPLIED IN PROXIMAL AND DISTAL FALSE LUMEN AND SUTURE LINES IN A PATIENT WITH AORTIC DISSECTION IN (B)(6) 2014. ON (B)(6) CT SHOWED FALSE ANEURYSM IN DISTAL ASCENDING AORTA, THEN EMERGENCY OPERATION WAS PERFORMED. ANOTHER FALSE ANEURYSM WAS FOUND IN PROXIMAL ASCENDING AORTA DURING THE OPERATION. THE FALSE ANEURYSM WAS BETWEEN RIGHT CORONARY CUSP AND LEFT CORONARY CUSP (CLOSER TO THE RIGHT CORONARY CUSP). BENTALL AND HEMIARCH AORTIC REPLACEMENT WERE PERFORMED IN THE RE-OPERATION. AT THE RE-OPERATION, IT WAS FOUND THAT BIOGLUE WHICH HAD BEEN USED IN THE INITIAL OPERATION DID NOT ADHERE WITH THE TISSUE. PUMP OXYGENATOR WAS USED FOR 12 HOURS IN THE OPERATION. AFTER THE SURGERY, PCPS AND IABP (INTRA-AORTIC BALLOON PUMPING) WERE USED IN ICU, HOWEVER THE PATIENT DIED EIGHT HOURS AFTER BEING TRANSPORTED TO THE ICU. ADDITIONAL INFORMATION WAS OBTAINED FROM THE SURGEON THAT THE APPLICATION SITE WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND THE AMOUNT OF THE APPLIED BIOGLUE WAS A PROPER QUANTITY (TWO SYRINGES). AT THE TIME OF APPLICATION DURING THE INITIAL PROCEDURE, BIOGLUE WAS ADHERING TO THE TISSUE. THE FALSE ANEURYSM WAS FOUND ON AN AREA WHERE BIOGLUE WAS NOT APPLIED DURING THE INITIAL PROCEDURE. POSSIBLE LOT NUMBERS WERE DETERMINED FROM SHIPPING RECORDS AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE CAUSE OF THE PSEUDOANEURYSMS OBSERVED IN THIS PATIENT COULD NOT DEFINITIVELY BE DETERMINED. THE SURGEON INDICATED THAT ONE OF THE FALSE ANEURYSMS OCCURRED IN A LOCATION IN WHICH BIOGLUE WAS NOT APPLIED; THEREFORE IT IS UNLIKELY THAT BIOGLUE CAUSED OR CONTRIBUTED TO THAT FALSE ANEURYSM FORMATION. THE SURGEON INDICATED THAT A SECOND FALSE ANEURYSM WAS OBSERVED IN THE PROXIMAL ASCENDING AORTA; HOWEVER, IT IS UNCLEAR IF IT OCCURRED IN AN AREA WHERE BIOGLUE WAS APPLIED. THEREFORE, IT CANNOT BE DETERMINED IF BIOGLUE CAUSED OR CONTRIBUTED TO THAT FALSE ANEURYSM. THE SURGEON ALSO STATED THAT THE BIOGLUE ADHERED TO THE TISSUE DURING APPLICATION BUT THAT UPON REOPERATION THE BIOGLUE THAT HAD BEEN USED IN THE PRIMARY PROCEDURE DID NOT ADHERE WITH THE TISSUE. IT IS UNCLEAR IF THE SURGEON IS REFERRING TO THE BIOGLUE DELIVERED INTO THE FALSE LUMEN, THE BIOGLUE APPLIED TO THE ANASTOMOSES, OR BOTH. ALSO, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CUSTOMER STATED THAT ALTHOUGH PRIMING OCCURRED, IT MAY HAVE BEEN INSUFFICIENT. UNLESS THE APPLICATION SITES WERE NOT PROPERLY PREPARED (I.E., CLEARED OF ANY THROMBUS AND/OR DEBRIS AND A TEMPORARY DRY FIELD OBTAINED) AND/OR THE BIOGLUE SYRINGE WAS NOT PROPERLY PREPARED, BIOGLUE WOULD REMAIN ADHERED TO THE TISSUE. THE STRENGTH OF THE COVALENT BONDING WOULD PREVENT BIOGLUE FROM PASSIVELY BECOMING NON-ADHERED AS BIOGLUE MUST BE TRIMMED AWAY WITH SCISSORS ONCE ADHERED TO TISSUE. IF THE BIOGLUE WAS TRULY NOT ADHERED UPON REOPERATION, THE BIOGLUE WOULD NOT HAVE BEEN FULLY ADHERED AT APPLICATION WHICH WOULD INDICATE THAT THE SITE WAS NOT PROPERLY PREPARED PRIOR TO APPLICATION. THERE IS NOT ENOUGH INFORMATION PROVIDED IN THIS COMPLAINT TO DETERMINE THE CAUSE OF DEATH IN THIS PATIENT OR WHETHER OR NOT BIOGLUE CONTRIBUTED TO THE PATIENT'S DEATH. PSEUDOANEURYSM IS A KNOWN POTENTIAL COMPLICATION TO AORTIC DISSECTION REPAIR. ADEQUATE PRECAUTIONS ARE PROVIDED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    BIOGLUE WAS APPLIED IN PROXIMAL AND DISTAL FALSE LUMEN AND SUTURE LINES IN A PATIENT WITH AORTIC DISSECTION IN (B)(6) 2014. ON JUNE (B)(6) 2014, CT SHOWED FALSE ANEURYSM IN DISTAL ASCENDING AORTA, THEN EMERGENCY OPERATION WAS PERFORMED. ANOTHER FALSE ANEURYSM WAS FOUND IN PROXIMAL ASCENDING AORTA DURING THE OPERATION. THE FALSE ANEURYSM WAS BETWEEN RIGHT CORONARY CUSP AND LEFT CORONARY CUSP (CLOSER TO THE RIGHT CORONARY CUSP). BENTALL AND HEMIARCH AORTIC REPLACEMENT WERE PERFORMED IN THE RE-OPERATION. AT THE RE-OPERATION, IT WAS FOUND THAT BIOGLUE WHICH HAD BEEN USED IN THE INITIAL OPERATION DID NOT ADHERE WITH THE TISSUE. PUMP OXYGENATOR WAS USED FOR 12 HOURS IN THE OPERATION. AFTER THE SURGERY, PCPS AND IABP (INTRA-AORTIC BALLOON PUMPING) WERE USED IN ICU, HOWEVER, THE PATIENT DIED EIGHT HOURS AFTER BEING TRANSPORTED TO THE ICU.

    Description of Event or Problem · 1

    BIOGLUE WAS APPLIED IN PROXIMAL AND DISTAL FALSE LUMEN AND SUTURE LINES IN A PATIENT WITH AORTIC DISSECTION IN (B)(6) 2014. ON (B)(6) 2014, CT SHOWED FALSE ANEURYSM IN DISTAL ASCENDING AORTA, THEN EMERGENCY OPERATION WAS PERFORMED. ANOTHER FALSE ANEURYSM WAS FOUND IN PROXIMAL ASCENDING AORTA DURING THE OPERATION. THE FALSE ANEURYSM WAS BETWEEN RIGHT CORONARY CUSP AND LEFT CORONARY CUSP (CLOSER TO THE RIGHT CORONARY CUSP). BENTALL AND HEMIARCH AORTIC REPLACEMENT WERE PERFORMED IN THE RE-OPERATION. AT THE RE-OPERATION, IT WAS FOUND THAT BIOGLUE WHICH HAD BEEN USED IN THE INITIAL OPERATION DID NOT ADHERE WITH THE TISSUE. PUMP OXYGENATOR WAS USED FOR 12 HOURS IN THE OPERATION. AFTER THE SURGERY, PCPS AND IABP (INTRA-AORTIC BALLOON PUMPING) WERE USED IN ICU, HOWEVER THE PATIENT DIED EIGHT HOURS AFTER BEING TRANSPORTED TO THE ICU.

    Description of Event or Problem · 1

    BIOGLUE WAS APPLIED IN PROXIMAL AND DISTAL FALSE LUMEN AND SUTURE LINES IN A PATIENT WITH AORTIC DISSECTION IN (B)(6) 2014. ON (B)(6) 2014, CT SHOWED FALSE ANEURYSM IN DISTAL ASCENDING AORTA, THEN EMERGENCY OPERATION WAS PERFORMED. ANOTHER FALSE ANEURYSM WAS FOUND IN PROXIMAL ASCENDING AORTA DURING THE OPERATION. THE FALSE ANEURYSM WAS BETWEEN RIGHT CORONARY CUSP AND LEFT CORONARY CUSP (CLOSER TO THE RIGHT CORONARY CUSP). BENTALL AND HEMIARCH AORTIC REPLACEMENT WERE PERFORMED IN THE RE-OPERATION. AT THE RE-OPERATION, IT WAS FOUND THAT BIOGLUE WHICH HAD BEEN USED IN THE INITIAL OPERATION DID NOT ADHERE WITH THE TISSUE. PUMP OXYGENATOR WAS USED FOR 12 HOURS IN THE OPERATION. AFTER THE SURGERY, PCPS AND IABP (INTRA-AORTIC BALLOON PUMPING) WERE USED IN ICU, HOWEVER THE PATIENT DIED EIGHT HOURS AFTER BEING TRANSPORTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361561 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O| S