BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE - UNKNOWN CONFIGURATION

    MDR report key: 24182920 · Received January 26, 2026

    Report

    Report Number
    1063481-2026-00005
    Event Type
    Death
    Date Received
    January 26, 2026
    Report Date
    March 5, 2026
    Manufacturer
    ARTIVION, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETROSPECTIVE PUBLICATION ¿DOES BIOGLUE CONTRIBUTE TO ANASTOMOTIC PSEUDOANEURYSM AFTER THORACIC AORTIC SURGERY?¿ WEI-GUO MA, BULAT A. ZIGANSHIN, CHANG-FA GUO, MOHAMMAD A. ZAFAR, RICHARD S. SIELLER, MARYANN TRANQUILLI, JOHN A. ELEFTERIADES WAS RECEIVED. A QUERY OF COMPLAINT RECORDS REVEALED THIS ARTICLE WAS INVESTIGATED IN COMPLAINT (B)(4). AS THIS INFORMATION WAS DISCOVERED AFTER A REPORT WAS SUBMITTED TO THE FDA, THIS FOLLOW-UP REPORT WILL BE FILED IDENTIFYING THE MFR REPORT # 1063481-2017-00030 AS THE ORIGINAL SUBMISSION FOR THIS EVENT. PLEASE REFERENCE MFR REPORT # 1063481-2017-00030 FOR ADDITIONAL DETAILS.

    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 ¿ FORMERLY CRYOLIFE/JOTEC.

    Description of Event or Problem · 0

    ACCORDING TO RETROSPECTIVE PUBLICATION ¿DOES BIOGLUE CONTRIBUTE TO ANASTOMOTIC PSEUDOANEURYSM AFTER THORACIC AORTIC SURGERY?¿ WEI-GUO MA, BULAT A. ZIGANSHIN, CHANG-FA GUO, MOHAMMAD A. ZAFAR, RICHARD S. SIELLER, MARYANN TRANQUILLI, JOHN A. ELEFTERIADES. ¿THE DATABASE OF THE AORTIC INSTITUTE AT YALE-NEW HAVEN HOSPITAL WAS REVIEWED TO IDENTIFY PATIENTS IN WHOM BIOGLUE WAS USED DURING THEIR AORTIC SURGICAL PROCEDURES BETWEEN JULY 2001 AND MAY 2015.¿ ¿A TOTAL OF 233 PATIENTS WITH BIOGLUE USE WERE IDENTIFIED.¿ ¿ALTHOUGH SEVERAL ANIMAL STUDIES AND CLINICAL REPORTS HAVE ILLUMINATED THE BENEFITS OF USING BIOGLUE IN AORTIC SURGICAL OPERATIONS OVER THE PAST 15 YEARS (8-11), SOME REPORTS SUGGEST THAT BIOGLUE MAY SEVERELY INJURE THE AORTIC TISSUE, ULTIMATELY LEADING TO RE-DISSECTION OR PSEUDOANEURYSM FORMATION AT THE ANASTOMOTIC SITES (1,9,10,12-16). THIS STUDY INCREASES THE PATIENT NUMBER OF AN EARLIER PILOT STUDY WE PUBLISHED PREVIOUSLY (14) AND AIMS TO EXAMINE WHETHER THE USE OF BIOGLUE IS ASSOCIATED WITH A HIGH INCIDENCE OF ANASTOMOTIC PSEUDOANEURYSM FORMATION FOLLOWING SURGICAL REPAIR OF THORACIC AORTIC DISEASE.¿ CONCLUSION: ¿IN THIS SERIES, THE USE OF BIOGLUE IN THORACIC AORTIC SURGERY WAS ASSOCIATED WITH A VERY LOW INCIDENCE OF ANASTOMOTIC PSEUDOANEURYSM FORMATION IN PATIENTS WHO SURVIVED THE OPERATION. ITS USE NEED NOT BE DISCOURAGED ON THIS BASIS FOR PATIENTS WITH ACUTE AORTIC DISSECTION OR EXTREME TISSUE FRAGILITY.¿ THIS INVESTIGATION IS RELEGATED TO BIOGLUE SURGICAL ADHESIVE UNKNOWN CONFIGURATION FOR THE FOLLOWING EVENTS: ANASTOMOTIC PSEUDOANEURYSM 1 OPERATIVE DEATH (DEFINED AS ALL DEATHS OCCURRING DURING THE SAME HOSPITALIZATION IN WHICH THE OPERATION WAS PERFORMED EVEN IF AFTER 30 DAYS OR AFTER DISCHARGE BUT WITHIN 30 POSTOPERATIVE DAYS) OCCURRED IN 17 PATIENTS (7.3%). DEATHS ATTRIBUTED TO THE FOLLOWING: VENTRICULAR FIBRILLATION IN 6 PATIENTS (2.6%), STROKE IN 5 (2.1%), LOW CARDIAC OUTPUT IN 3 (1.3%), BLEEDING IN 2 (0.8%) AND RESPIRATORY FAILURE IN 1 (0.4%). ADDITIONAL EVENTS INCLUDE: RE-EXPLORATION FOR BLEEDING WAS REQUIRED IN 24 (10.3%) CASES. NEUROLOGIC COMPLICATIONS OCCURRED IN 22 CASES IN 19 PATIENTS (9.0%, SOME MULTIPLE), INCLUDING STROKE IN 9 (3.9%), PARALYSIS IN 6 (2.6%), TRANSIENT ISCHEMIC ATTACK IN 4 (1.7%), AND COMA/ENCEPHALOPATHY IN 3 (1.3%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95029 BIOGLUE - UNKNOWN CONFIGURATION GLUE,SURGICAL,ARTERIES MUQ ARTIVION, INC. BG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L| D| O