BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 20677183 · Received November 13, 2024

    Report

    Report Number
    2124215-2024-71320
    Event Type
    Death
    Date Received
    November 13, 2024
    Date of Event
    March 27, 2024
    Report Date
    November 13, 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 DEATH OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME (ACS) AND UNSTABLE ANGINA. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED 1ST DIAGONAL BRANCH. TREATMENT WITH A 2.00 MM X 20.00 MM AGENT DCB WAS COMPLETED ON (B)(6) 2023. LATE IN THE EVENING ON (B)(6) 2024, THE PATIENT WAS FOUND IN RESPIRATORY ARREST. EMERGENCY MEDICAL SERVICES WAS CONTACTED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL'S EMERGENCY ROOM. JUST AFTER MIDNIGHT ON (B)(6) 2024, PULSE CHECK AND WAVEFORM WERE PERFORMED WHICH CONFIRMED CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED BUT WAS DISCONTINUED AFTER ABOUT 13 MINUTES. THE PATIENT WAS CONFIRMED TO BE DEAD OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009103 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death