BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 20103083 · Received August 29, 2024

    Report

    Report Number
    2124215-2024-53916
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 29, 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 RESTENOSIS OF THE TARGET LESION OCCURRED. ON (B)(6) 2024, AN AGENT DCB MR 3.50 X 15MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION, WHICH WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SYMPTOMS OF ANGINA. A CORONARY ANGIOGRAM REVEALED THAT RESTENOSIS HAD OCCURRED IN THE PROXIMAL RCA. A REVASCULARIZATION PROCEDURE WAS PERFORMED ON THE SAME DAY WITH NO FURTHER PATIENT COMPLICATIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522681 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention