BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 20258891 · Received September 19, 2024

    Report

    Report Number
    2124215-2024-57171
    Event Type
    Death
    Date Received
    September 19, 2024
    Date of Event
    June 23, 2024
    Report Date
    September 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    JAPAN AGENT ALLIANCE REGISTRY. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2024, THE RCA WAS TREATED WITH A 3.50 MM X 15.00 MM AGENT DCB. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED. SUBSEQUENTLY, THE PATIENT DEVELOPED HEART FAILURE AND RECEIVED TREATMENT, BUT ON (B)(6) 2024, THE PATIENT SUDDENLY WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND THE HEART RHYTHM WAS RESTORED. HOWEVER, THE FAMILY DID NOT WISH FOR FURTHER INVASIVE TREATMENT. ON (B)(6) 2024, THE PATIENT EXPERIENCED ANOTHER CARDIAC ARREST AND PASSED AWAY, RESULTING IN DISCHARGE DUE TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786552 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death