BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 23709134 · Received December 3, 2025

    Report

    Report Number
    1063481-2025-00118
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    June 17, 2025
    Report Date
    February 3, 2026
    Manufacturer
    ARTIVION, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE EVALUATION WAS NOT PERFORMED AS NO PRODUCT WAS EXPLANTED. 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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND TO BE RELATED TO THE COMPLAINT. ACCORDING TO THE REPORT RECEIVED, THE PATIENT UNDERWENT ASCENDING AORTA ANEURYSM TREATMENT WITH THE USE OF BIOGLUE ON (B)(6) 2024 AND HAS SINCE HAD CHRONIC HYPEREOSINOPHILIA. FOR THIS SPECIFIC EVENT THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A DEFINITIVE ROOT CAUSE OF THE SUSPECTED HYPEREOSINOPHILIA. NO SAMPLE WAS RETURNED TO ARTIVION FOR EVALUATION AND NO PATHOLOGY. MEDICAL RECORDS PROVIDED BY THE HOSPITAL WERE REVIEWED. IT IS UNKNOWN IF BIOGLUE WAS USED PROPERLY DURING THE PROCEDURE. BIOGLUE IS INDICATED FOR REPAIR OF ASCENDING AORTA ANEURYSM TREATMENT, IF USED ACCORDING TO IFU. INFLAMMATORY REACTIONS (SUCH AS EOSINOPHILIA) HAVE BEEN REPORTED IN THE LITERATURE. AS INFLAMMATION IS LISTED AS A POTENTIAL ADVERSE EVENT, THIS IS NOT AN UNEXPECTED EVENT. THIS CASE DOES NOT SHOW A NEW ADVERSE EVENT RELATED TO THE USE OF BIOGLUE. THE BIOGLUE AFMEA-0001 AND DFMEA-0001 WERE REVIEWED. THE REPORTED EVENTS ARE ADDRESSED. THE REPORTED PRODUCT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO ISSUES WERE FOUND THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. AS INFLAMMATION IS LISTED AS A POTENTIAL ADVERSE EVENT, THIS IS NOT AN UNEXPECTED EVENT. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. 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- FORMERLY CRYOLIFE/JOTEC 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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, "PATIENT DEVELOPED HYPEREOSINOPHILIA SYNDROME [ON (B)(6) 2025] AFTER THE SURGICAL PROCEDURE. THE INITIAL PROCEDURE (ASCENDING AORTA ANEURYSM TREATMENT) TOOK PLACE ON (B)(6) 2024.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2862859 BIOGLUE SURGICAL ADHESIVE GLUE, SURGICAL, ARTERIES MUQ ARTIVION, INC. BG3510-5-G BG001195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other