BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE-UNKNOWN CONFIGURATION

    MDR report key: 23509880 · Received November 10, 2025

    Report

    Report Number
    1063481-2025-00109
    Event Type
    Injury
    Date Received
    November 10, 2025
    Report Date
    December 30, 2025
    Manufacturer
    ARTIVION, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A SAMPLE EVALUATION WAS NOT PERFORMED AS NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THE AVAILABLE INFORMATION WAS REVIEWED. ACCORDING TO THE INITIAL NOTIFICATION VIA EMAIL FROM ON 10/15/2025, "THIS IS TO REPORT TO YOU A NEW COMPLAINT. PLEASE FIND THE ATTACHED COMPLAINT REPORT. THE REPORTABILITY DECISION FOR THIS EVENT IS REPORTABLE (30-DAY)." ACCORDING TO (B)(4): DID THE PATIENT DEVELOP ANY UNEXPECTED POST-OPERATIVE EVENTS THOUGHT TO BE RELATED TO THE USE OF BIOGLUE? IF YES, PLEASE DESCRIBE. "THIS EVENT WAS PRESENTED AT AN ACADEMIC CONFERENCE. ¿WE PRESENT THE CASE OF A 27-YEAR-OLD MALE WHO COLLAPSED DUE TO SEVERE STENOSIS OF AN ARTIFICIAL VESSEL CAUSED BY A PSEUDOANEURYSM AT THE CENTRAL ANASTOMOTIC SITE AFTER ACUTE AORTIC DISSECTION STANFORD TYPE A. ALTHOUGH WE BELIEVE THAT BIOGLUE MEDIATED TISSUE TOXICITY MAY BE ONE CAUSE OF THIS PSEUDOANEURYSM, OTHER FACTORS, SUCH AS TISSUE SEPARATION DUE TO TISSUE FRAGILITY CAUSED BY INFECTION, INFLAMMATION, AND CUTTING CAUSED BY THE SURGICAL PROCEDURE, ARE ALSO THOUGHT TO HAVE CONTRIBUTED. EMERGENCY RE-OPERATION WAS PERFORMED AFTER RESUSCITATION. THE PATIENT WAS EVENTUALLY DISCHARGED HOME WITHOUT ADVERSE EVENTS ON THE 34TH POSTOPERATIVE DAY. CAREFUL OBSERVATION IN MID- TO LONG-TERM AND REMOTE POST-OPERATIVE PHASES IS NECESSARY FOR PATIENTS SUBJECTED TO PROCEDURES USING BIOGLUE, AND PROMPT REPAIR OF PSEUDOANEURYSMS IS DESIRABLE.¿ THIS INVESTIGATION IS RELEGATED TO BG UNKNOWN CONFIGURATION, UNKNOWN LOT NUMBER, WITH THE ALLEGATION OF CONTRIBUTING TO PSEUDOANEURYSM/REOPERATION. FOR THIS SPECIFIC EVENT THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A DEFINITIVE ROOT CAUSE OF THE SUSPECTED PSEUDOANEURYSM. NO SAMPLE WAS RETURNED TO ARTIVION FOR EVALUATION AND NO PATHOLOGY OR MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. IT IS ALSO UNKNOWN BIOGLUE WAS USED PROPERLY DURING THE PROCEDURE. BIOGLUE IS INDICATED FOR REPAIR OF TYPE A DISSECTIONS, IF USED ACCORDING TO IFU. PSEUDOANEURYSM HAS BEEN REPORTED IN THE LITERATURE. AS PSEUDOANEURYSM 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. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF IFU SHOWS ADEQUATE PRECAUTIONS AND WARNINGS PROVIDED ABOUT THE POTENTIAL FOR PSEUDOANEURYSM. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION, PREVIOUSLY CRYOLIFE/JOTEC. 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.

    Description of Event or Problem · 0

    ACCORDING TO INITIAL NOTIFICATION: DID THE PATIENT DEVELOP ANY UNEXPECTED POST-OPERATIVE EVENTS THOUGHT TO BE RELATED TO THE USE OF BIOGLUE? IF YES, PLEASE DESCRIBE. "THIS EVENT WAS PRESENTED AT AN ACADEMIC CONFERENCE. ¿WE PRESENT THE CASE OF A 27-YEAR-OLD MALE WHO COLLAPSED DUE TO SEVERE STENOSIS OF AN ARTIFICIAL VESSEL CAUSED BY A PSEUDOANEURYSM AT THE CENTRAL ANASTOMOTIC SITE AFTER ACUTE AORTIC DISSECTION STANFORD TYPE A. ALTHOUGH WE BELIEVE THAT BIOGLUE MEDIATED TISSUE TOXICITY MAY BE ONE CAUSE OF THIS PSEUDOANEURYSM, OTHER FACTORS, SUCH AS TISSUE SEPARATION DUE TO TISSUE FRAGILITY CAUSED BY INFECTION, INFLAMMATION, AND CUTTING CAUSED BY THE SURGICAL PROCEDURE, ARE ALSO THOUGHT TO HAVE CONTRIBUTED. EMERGENCY RE-OPERATION WAS PERFORMED AFTER RESUSCITATION. THE PATIENT WAS EVENTUALLY DISCHARGED HOME WITHOUT ADVERSE EVENTS ON THE 34TH POSTOPERATIVE DAY. CAREFUL OBSERVATION IN MID- TO LONG-TERM AND REMOTE POST-OPERATIVE PHASES IS NECESSARY FOR PATIENTS SUBJECTED TO PROCEDURES USING BIOGLUE, AND PROMPT REPAIR OF PSEUDOANEURYSMS IS DESIRABLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524452 BIOGLUE-UNKNOWN CONFIGURATION GLUE, SURGICAL, ARTERIES MUQ ARTIVION, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention| H