BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 20048625 · Received August 23, 2024

    Report

    Report Number
    2124215-2024-51111
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 22, 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

    ALLIANCE REGISTRY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND THROMBUS OCCURRED. ON (B)(6) 2023 , THE PATENT PRESENTED WITH STABLE ANGINA. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE TARGET LESION WAS TREATED WITH A 2.00 MM X 30.00 MM, 2.50 MM X 30.00 MM AND 3.00 MM X 30.00 MM AGENT DCB. ON (B)(6) 2024 , THE PATIENT WAS DEVELOPED A MYOCARDIAL INFARCTION IN THE EARLY MORNING AND UNDERWENT EMERGENCY REVASCULARIZATION. ALL ANTICOAGULANTS WERE DISCONTINUED AS OF (B)(6) 2024 IN PREPARATION FOR THE PLANNED SURGICAL TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM SCHEDULED FOR (B)(6) 2024. THE RED THROMBUS WAS CONFIRMED AT MID LAD. REVASCULARIZATION PERFORMED AT MID AND DISTAL LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698658 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention