BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN

    MDR report key: 21254016 · Received January 28, 2025

    Report

    Report Number
    1063481-2025-00002
    Event Type
    Death
    Date Received
    January 28, 2025
    Date of Event
    October 1, 2023
    Report Date
    March 18, 2025
    Manufacturer
    ARTIVION, INC. ¿ KENNESAW
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INITIAL NOTIFICATION FROM CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM ON (B)(6)2025, "THE PATIENT DEVELOPED MEDIAL DEGENERATION AND ACUTE AORTIC DISSECTION IN (B)(6) 2023. SUBSEQUENTLY, A BENTALL PROCEDURE WAS PERFORMED IN (B)(6) 2024. THE PATIENT ULTIMATELY DIED DUE TO RUPTURE OF THE SINUS OF VALSALVA. THE DATE OF DEATH WAS NOT REPORTED. IT WAS REPORTED THAT AN ALLERGIC REACTION WAS OBSERVED IN THE AORTIC WALL. WE ATTEMPTED TO OBTAIN INFORMATION SUCH AS THE LOT NUMBER OF THE BIOGLUE USED, THE METHOD OF USE, AND THE PROCEDURES FOLLOWED, BUT WE WERE UNABLE TO GET ANY RESPONSES BEYOND WHAT IS STATED IN THIS FORM." THIS INVESTIGATION IS RELEGATED TO BG3510-5-J, UNKNOWN LOT NUMBER, WITH THE ALLEGATION OF ALLERGIC REACTION IN WHICH THE PATIENT ULTIMATELY DIED. POTENTIAL LOT NUMBERS FROM SAP 6 MONTH LOOKBACK FROM THE DATE OF PROCEDURE LISTED: BG000888, BG001035, BG000972, BG000985, BG001005, BG000948, BG000915 A SAMPLE EVALUATION WAS NOT PERFORMED AS NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THE MANUFACTURING RECORDS FOR BG3510-5-J, LOTS BG000888, BG001035, BG000972, BG000985, BG001005, BG000948, AND BG000915 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND TO BE RELATED TO THE COMPLAINT. THE AVAILABLE INFORMATION WAS REVIEWED. ACCORDING TO THE INITIAL NOTIFICATION FROM CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM ON (B)(6)2025, "THE PATIENT DEVELOPED MEDIAL DEGENERATION AND ACUTE AORTIC DISSECTION IN (B)(6)2023. SUBSEQUENTLY, A BENTALL PROCEDURE WAS PERFORMED IN (B)(6) 2024. THE PATIENT ULTIMATELY DIED DUE TO RUPTURE OF THE SINUS OF VALSALVA. THE DATE OF DEATH WAS NOT REPORTED. IT WAS REPORTED THAT AN ALLERGIC REACTION WAS OBSERVED IN THE AORTIC WALL. WE ATTEMPTED TO OBTAIN INFORMATION SUCH AS THE LOT NUMBER OF THE BIOGLUE USED, THE METHOD OF USE, AND THE PROCEDURES FOLLOWED, BUT WE WERE UNABLE TO GET ANY RESPONSES BEYOND WHAT IS STATED IN THIS FORM." THIS INVESTIGATION IS RELEGATED TO BG3510-5-J, UNKNOWN LOT NUMBER, WITH THE ALLEGATION OF ALLERGIC REACTION IN WHICH THE PATIENT ULTIMATELY DIED. POTENTIAL LOT NUMBERS FROM SAP 6 MONTH LOOKBACK: BG000888, BG001035, BG000972, BG000985, BG001005, BG000948, BG000915 BASED ON THE INFORMATION PROVIDED, INSUFFICIENT EVIDENCE IS PROVIDED TO DETERMINE WHAT CAUSED THE ALLEGED ALLERGIC REACTION. HOWEVER, A POTENTIAL REACTION TO BIOGLUE CANNOT BE EXCLUDED. THE FOLLOWING INFORMATION WAS NOT PROVIDED AND IS UNKNOWN: THE CONDITION OF THE NATIVE TISSUE, AND ANY CO-MORBIDITIES THE PATIENT MAY HAVE HAD. THERE ARE NO SURGICAL REPORTS OR MEDICAL RECORDS AVAILABLE. WE HAVE NO WAY TO EVALUATE IF BIOGLUE WAS APPLIED PER THE IFU. THE FOLLOWING IS PROVIDED IN THE APPLICABLE BIOGLUE INSTRUCTIONS FOR USE: ¿BIOGLUE IS NOT FOR PATIENTS WITH KNOWN SENSITIVITY TO MATERIALS OF BOVINE ORIGIN." ADDITIONALLY, THE FOLLOWING WARNING IS PROVIDED WITHIN THE IFU: "EXERCISE CAUTION WITH REPEAT EXPOSURE OF BIOGLUE IN THE SAME PATIENT. HYPERSENSITIVITY REACTIONS ARE POSSIBLE UPON EXPOSURE TO BIOGLUE. SENSITIZATION HAS BEEN OBSERVED IN ANIMALS." THE INSTRUCTIONS FOR USE ALSO LISTS DEATH AS AN OBSERVED UNDESIRABLE SIDE EFFECT/ADVERSE EVENT. THE ROOT CAUSE OF THE OBSERVED EVENT IS UNKNOWN. HOWEVER, A POTENTIAL REACTION TO BIOGLUE CANNOT BE EXCLUDED. A REVIEW OF IFU SHOWS ADEQUATE PRECAUTIONS AND WARNINGS PROVIDED ABOUT THE POTENTIAL FOR ALLERGIC REACTION. ADDITIONALLY, THE INSTRUCTIONS FOR USE LISTS DEATH AS AN OBSERVED UNDESIRABLE SIDE EFFECT/ADVERSE EVENT. NO FURTHER ACTION IS REQUIRED. THIS EVENT WAS REVIEWED. NO SAMPLES WERE RETURNED FOR INVESTIGATION AND A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED OVER A RANGE OF SEVEN (7) LOTS FROM A SIX (6) MONTH PERIOD SINCE THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE OBSERVED EVENT IS UNKNOWN. HOWEVER, A POTENTIAL REACTION TO BIOGLUE CANNOT BE EXCLUDED. A REVIEW OF IFU SHOWS ADEQUATE PRECAUTIONS AND WARNINGS PROVIDED ABOUT THE POTENTIAL FOR ALLERGIC REACTION. ADDITIONALLY, THE INSTRUCTIONS FOR USE LISTS DEATH AS AN OBSERVED UNDESIRABLE SIDE EFFECT/ADVERSE EVENT. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. A REVIEW OF IFU SHOWS ADEQUATE PRECAUTIONS AND WARNINGS PROVIDED ABOUT THE POTENTIAL FOR ALLERGIC REACTION. ADDITIONALLY, THE INSTRUCTIONS FOR USE LISTS DEATH AS AN OBSERVED UNDESIRABLE SIDE EFFECT/ADVERSE EVENT. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION, PREVIOUSLY CRYOLIFE/JOTEC; THEREFORE, A CAPA EVALUATION IS NOT WARRANTED AT THIS TIME. ARTIVION WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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 ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. 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 ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL NOTIFICATION FROM CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM ON (B)(6) 2025, "THE PATIENT DEVELOPED MEDIAL DEGENERATION AND ACUTE AORTIC DISSECTION IN (B)(6) 2023. SUBSEQUENTLY, A BENTALL PROCEDURE WAS PERFORMED IN (B)(6) 2024. THE PATIENT ULTIMATELY DIED DUE TO RUPTURE OF THE SINUS OF VALSALVA. THE DATE OF DEATH WAS NOT REPORTED. IT WAS REPORTED THAT AN ALLERGIC REACTION WAS OBSERVED IN THE AORTIC WALL. WE ATTEMPTED TO OBTAIN INFORMATION SUCH AS THE LOT NUMBER OF THE BIOGLUE USED, THE METHOD OF USE, AND THE PROCEDURES FOLLOWED, BUT WE WERE UNABLE TO GET ANY RESPONSES BEYOND WHAT IS STATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501740 BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN GLUE, SURGICAL, ARTERIES MUQ ARTIVION, INC. ¿ KENNESAW BG3510-5-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O