BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 20280926 · Received September 23, 2024

    Report

    Report Number
    2124215-2024-59378
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 23, 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 ALLIANCE REGISTRY IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE 100% STENOSED AND MILDLY CALCIFIED TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE LESION WAS TREATED WITH 4.00 MM X 20 MM AND 3.50 X 30 MM AGENT DCB DEVICES. 6 MONTHS LATER, A HEART COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS COMPLETED AND REVEALED SIGNIFICANT STENOSIS IN THE RIGHT CORONARY ARTERY. 2 WEEKS LATER, CORONARY ANGIOGRAPHY EXAMINATION WAS PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH RESTENOSIS IN THE RIGHT CORONARY ARTERY, WHICH WAS DETERMINED TO BE SEVERE. CORONARY FLOW RESERVE RATIO WAS 0.71, AND ISCHEMIA DIAGNOSIS WAS POSITIVE. REVASCULARIZATION WAS PERFORMED 2 WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591213 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention