BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 20038000 · Received August 22, 2024

    Report

    Report Number
    2124215-2024-51858
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    February 1, 2024
    Report Date
    August 21, 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

    IT WAS REPORTED THAT REVASCULARIZATION OCCURRED. ON (B)(6) 2023 AN AGENT DCB MR 2.75 X 30MM AND 2.25 X 30MM WERE SELECTED FOR TREATMENT OF THE TARGET LESION WHICH WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). LATER, ON (B)(6) 2024, THE PATIENT WAS EXPERIENCING CHEST PAIN. A CORONARY ANGIOGRAM PERFORMED ON (B)(6) 2024 REVEALED THAT RESTENOSIS HAS OCCURRED AT THE LAD. FURTHER TREATMENT USING A STENT WAS REQUIRED, AND THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19025 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825 02643H23

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown Other