BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 23435213 · Received October 31, 2025

    Report

    Report Number
    2124215-2025-78400
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    March 25, 2025
    Report Date
    October 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2025, THE PATIENT PRESENTED TO HOSPITAL WITH SHORTNESS OF BREATH AND CHEST PRESSURE. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL WHICH WERE CONTINUED. THE PATIENT WAS DIAGNOSED WITH RECURRENT ANGINA. DIAGNOSTIC CORONARY ANGIOGRAPHY REVEALED 80% IN STENT RESTENOSIS (ISR) AT THE RIGHT CORONARY ARTERY (RCA). THE OSTIAL LESION WAS SUCCESSFULLY TREATED WITH 3.50 MM X 30 MM AND 3.00 MM X 12 MM AGENT DCB BALLOONS SUCCESSFULLY. DURING THE SAME PROCEDURE, IN STENT RESTENOSIS AT THE MID-DISTAL RCA WAS TREATED WITH A 3.50 MM X 20 MM AGENT DCB DEVICE. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS NOTED AS 0% AND TIMI FLOW WAS 3. ON (B)(6) 2025, 70% IN-STENT RESTENOSIS AT THE MID RCA WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION DEVICES. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS NOTED AS 0% AND TIMI FLOW WAS 3. THE EVENT WAS CONSIDERED TO BE RESOLVED/RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2085605 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention