BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOGLUE - UNKNOWN CONFIGURATION

    MDR report key: 11626882 · Received April 7, 2021

    Report

    Report Number
    1063481-2021-00014
    Event Type
    Death
    Date Received
    April 7, 2021
    Report Date
    May 4, 2021
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO KONDO, S. ET AL., ¿AORTIC ROOT CONTRIVANCE OF ANASTOMOTIC STUMP FORMATION TREATMENT FOR ACUTE A-TYPE DISSECTION.¿ PREOPERATIVE, INTRAOPERATIVE, AND POSTOPERATIVE FACTORS AND REMOTE STAGE RESULTS WERE EXAMINED IN 67 PATIENTS. TOTAL ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK METHOD (TAR + FET) USED TO REPAIR AAAD WITH THE RELEASE CAVITY GLUED WITH BIOGLUE. IN-HOSPITAL DEATHS WAS 2 (3%), SPINAL CORD INJURY IN 2 CASES (3%), AND CEREBRAL INFARCTION IN 5 CASES (7%). ONE PATIENT DIED FROM CANCER WITHIN AVERAGE 48-MONTH FOLLOW-UP TIME. NO REOPERATION SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527032 BIOGLUE - UNKNOWN CONFIGURATION GLUE,SURGICAL,ARTERIES MUQ CRYOLIFE, INC. BG UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| O