BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 19726740 · Received July 11, 2024

    Report

    Report Number
    2124215-2024-43067
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    March 25, 2024
    Report Date
    July 11, 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 THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED WITH COMPLAINTS OF FATIGUE AND DECREASED OXYGEN SATURATION AND WAS DIAGNOSED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). A 2.00 X 30 MM AGENT DCB WAS USED TO COMPLETE PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT CIRCUMFLEX (LCX) AND THE PATIENT WAS DISCHARGED 10 DAYS LATER. 3 MONTHS LATER, THE PATIENT PRESENTED WITH NO SUBJECTIVE SYMPTOMS, BUT A BLOOD SAMPLE REVEALED AN INCREASED WHITE BLOOD CELL (WBC) COUNT. ELECTROCARDIOGRAM AND ECHOCARDIOGRAM SHOWED FEW FINDINGS OF SUSPECTING NEW ISCHEMIC CHANGES. BLOOD TESTING ALSO SHOWED POSITIVE TNI AND ELEVATED CKMB LEVEL, SO THE PATIENT WAS DIAGNOSED WITH NSTEMI, AND CARDIAC CATHETERIZATION WAS PERFORMED. ANGIOGRAPHY REVEALED THAT THE LCX AREA PREVIOUSLY TREATED WITH THE AGENT DCB WAS OCCLUDED. A 2.00 X 18 MM NON-BOSTON SCIENTIFIC STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426606 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