BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 19560517 · Received June 18, 2024

    Report

    Report Number
    2124215-2024-37169
    Event Type
    Death
    Date Received
    June 18, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 18, 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 PATIENT DEATH OCCURRED. ON AN UNSPECIFIED DATE, A DRUG-ELUTING STENT IMPLANTED INTO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE 90% STENOSED TARGET LESION WAS NON TORTUOUS AND MODERATELY CALCIFIED HIGH LATERAL LESION. ON (B)(6) 2024, THE TARGET LESION WAS TREATED WITH A 2.00 MM X 15.00 MM AGENT (DCB) DRUG-COATED BALLOON. THE PATIENT WAS TAKING BAYER ASPIRIN AND CLOPIDOGREL ORALLY. AFTER THE SURGERY, THE PATIENT RECOVERED, AND PATIENT'S CONDITION IMPROVED WITHOUT ANY PROBLEMS. ON (B)(6) 2024, THE PATIENT DIED AT HOME AFTER FEELING UNWELL SINCE THE PREVIOUS NIGHT. IT WAS CONFIRMED IT WAS A CARDIAC DEATH. THE DEATH WAS TREATED AS A MYOCARDIAL INFARCTION WITHOUT ANY AUTOPSY PERFORMED. IN THE PHYSICIAN'S OPINION, IT SEEMED UNDENIABLE THAT BOTH THE REMAINING LESION AND THE TREATED LESION COULD HAVE BEEN RELATED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652057 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death