BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 4131351 · Received October 1, 2014

    Report

    Report Number
    1063481-2014-00042
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 26, 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. 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.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED APPROXIMATELY ONE YEAR AGO (AROUND (B)(6) 2013) IN A "REPLACEMENT ASCENDING AORTA SURGERY" PROCEDURE FOR TYPE A ACUTE ASCENDING AORTA DISSECTION. BIOGLUE WAS APPLIED TO THE PROXIMAL AND DISTAL SUTURE LINES AND PROXIMAL AND DISTAL FALSE LUMEN. THE AMOUNT OF BIOGLUE APPLIED PER SITE IS UNKNOWN. IT IS ALSO UNKNOWN IF OTHER MATERIALS WERE USED FOR REINFORCEMENT, IF THE TARGET FIELD WAS DRY, IF THE VESSEL OR GRAFT WAS CLAMPED AND DEPRESSURIZED, AND THE CONDITION OF THE NATIVE TISSUE IS UNKNOWN. BIOGLUE WAS USED AS AN ADJUNCT TO SUTURES, BUT THE SUTURING TECHNIQUE IS UNKNOWN. BIOGLUE WAS NOT USED IN A CONTAMINATED OR INFECTED AREA. A CT SCAN SHOWED FALSE ANEURYSM AT THE END OF (B)(6). "FALSE ANEURYSM (RUPTURE) WAS RECOGNIZED DISTAL OF ASCENDING AORTA THAT BIOGLUE WAS APPLIED IN INITIAL PROCEDURE." THE PATIENT IS UNDER OBSERVATION; RE-PROCEDURE WAS NOT CONDUCTED BECAUSE THE PATIENT HAS THE PATIENT'S FAMILY DOES NOT WISH FOR A RE-PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE. RECORDS WERE REVIEWED FOR POSSIBLE LOT NUMBERS 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, A CAUSE OF THE "FALSE ANEURYSM (RUPTURE)" OBSERVED IN THE PATIENT COULD NOT DEFINITIVELY BE DETERMINED. THE DESCRIPTION OF THE EVENT THAT ACTUALLY OCCURRED IS UNCLEAR AS SURVIVAL FROM A RUPTURE IS NOT TYPICAL. MUCH INFORMATION IS UNKNOWN ABOUT THE USE OF BIOGLUE, INCLUDING THE AMOUNT OF BIOGLUE APPLIED, THE CONDITION OF THE TISSUE/TISSUE INTEGRITY PRIOR TO BIOGLUE APPLICATION AND FOLLOWING THE OBSERVED EVENT, WHETHER OR NOT THE FIELD WAS PROPERLY PREPARED PRIOR TO BIOGLUE APPLICATION, WHETHER OR NOT THE SYRINGE WAS PROPERLY PREPARED, WHETHER OR NOT THE PATIENT HAD UNDERLYING CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE EVENT, THE SUTURING TECHNIQUE USED, OR IF OTHER ADJUNCTIVE MEASURES/PRODUCTS WERE EMPLOYED OR USED. A CT WAS PERFORMED, BUT THE IMAGING HAS NOT BEEN MADE AVAILABLE FOR REVIEW. BECAUSE A REOPERATION HAS NOT BEEN PERFORMED, AND LIKELY WILL NOT BE PERFORMED, NO PATHOLOGICAL EXAMINATION HAS BEEN CONDUCTED. THE COMPLAINANT STATES THAT THE LOCATION OF THE "FALSE ANEURYSM (RUPTURE)" WAS "DISTAL OF ASCENDING AORTA THAT BIOGLUE WAS APPLIED IN INITIAL PROCEDURE." IT IS ASSUMED THAT THIS IS INTENDED TO MEAN THAT THE FALSE ANEURYSM WAS OBSERVED IN THE ASCENDING AORTA, DISTAL TO THE LOCATION OF THE APPLICATION OF BIOGLUE IN THE INITIAL PROCEDURE. BASED ON THIS INFORMATION, IT IS NOT LIKELY THAT BIOGLUE CAUSED OR CONTRIBUTED TO THE FORMATION OF THE FALSE ANEURYSM IN THIS PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED APPROXIMATELY ONE YEAR AGO (AROUND (B)(6) 2013) IN A "REPLACEMENT ASCENDING AORTA SURGERY" PROCEDURE FOR TYPE A ACUTE ASCENDING AORTA DISSECTION. BIOGLUE WAS APPLIED TO THE PROXIMAL AND DISTAL SUTURE LINES AND PROXIMAL AND DISTAL FALSE LUMEN. THE AMOUNT OF BIOGLUE APPLIED PER SITE IS UNKNOWN. IT IS ALSO UNKNOWN IF OTHER MATERIALS WERE USED FOR REINFORCEMENT, IF THE TARGET FIELD WAS DRY, IF THE VESSEL OR GRAFT WAS CLAMPED AND DEPRESSURIZED, AND THE CONDITION OF THE NATIVE TISSUE IS UNKNOWN. BIOGLUE WAS USED AS AN ADJUNCT TO SUTURES, BUT THE SUTURING TECHNIQUE IS UNKNOWN. BIOGLUE WAS NOT USED IN A CONTAMINATED OR INFECTED AREA. A CT SCAN SHOWED FALSE ANEURYSM AT THE END OF AUGUST. "FALSE ANEURYSM (RUPTURE) WAS RECOGNIZED DISTAL OF ASCENDING AORTA THAT BIOGLUE WAS APPLIED IN INITIAL PROCEDURE." THE PATIENT IS UNDER OBSERVATION; RE-PROCEDURE WAS NOT CONDUCTED BECAUSE THE PATIENT HAS THE PATIENT'S FAMILY DOES NOT WISH FOR A RE-PROCEDURE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE WAS USED APPROXIMATELY ONE YEAR AGO (AROUND (B)(6)2013) IN A "REPLACEMENT ASCENDING AORTA SURGERY" PROCEDURE FOR TYPE A ACUTE ASCENDING AORTA DISSECTION. BIOGLUE WAS APPLIED TO THE PROXIMAL AND DISTAL SUTURE LINES AND PROXIMAL AND DISTAL FALSE LUMEN. THE AMOUNT OF BIOGLUE APPLIED PER SITE IS UNKNOWN. IT IS ALSO UNKNOWN IF OTHER MATERIALS WERE USED FOR REINFORCEMENT, IF THE TARGET FIELD WAS DRY, IF THE VESSEL OR GRAFT WAS CLAMPED AND DEPRESSURIZED, AND THE CONDITION OF THE NATIVE TISSUE IS UNKNOWN. BIOGLUE WAS USED AS AN ADJUNCT TO SUTURES, BUT THE SUTURING TECHNIQUE IS UNKNOWN. BIOGLUE WAS NOT USED IN A CONTAMINATED OR INFECTED AREA. A CT SCAN SHOWED FALSE ANEURYSM AT THE END OF (B)(6). "FALSE ANEURYSM (RUPTURE) WAS RECOGNIZED DISTAL OF ASCENDING AORTA THAT BIOGLUE WAS APPLIED IN INITIAL PROCEDURE." THE PATIENT IS UNDER OBSERVATION; RE-PROCEDURE WAS NOT CONDUCTED BECAUSE THE PATIENT HAS THE PATIENT'S FAMILY DOES NOT WISH FOR A RE-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611205 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC. BG3510-5-J

    Patients

    Seq Age Sex Outcome Treatment
    1 Other