BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 19202762 · Received April 29, 2024

    Report

    Report Number
    2124215-2024-25743
    Event Type
    Death
    Date Received
    April 29, 2024
    Date of Event
    November 1, 2023
    Report Date
    April 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

    Additional Manufacturer Narrative · 0

    A4 WEIGHT: 69.9 KG. B3 DATE OF EVENT: ESTIMATED TO CAPTURE APPROXIMATE ONSET OF EXPERIENCED VENTRICULAR TACHYCARDIA.

    Description of Event or Problem · 0

    JAPAN ALLIANCE REGISTRY .IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH ST ELEVATION ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK ON (B)(6) 2023. CORONARY ANGIOGRAPHY SHOWED 90% STENOSIS IN THE LEFT MAIN TRUNK ORIGIN (LMT-LAD) AND 90% STENOSIS IN THE MILDLY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX). THAT SAME DAY, THE LMT-LAD WAS TREATED WITH A 3.50 X 48 MM SYNERGY AND THE LCX WAS TREATED WITH A 2.75 X 15 MM AGENT DCB AND THE ASSISTANCE OF A HEART PUMP. THE PATIENT WAS HOSPITALIZED TO UNDERGO CARDIAC REHABILITATION AND NON-SUSTAINED VENTRICULAR TACHYCARDIA WAS NOTED. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED WITH A WEARABLE CARDIOVERTER-DEFIBRILLATOR (WCD), BUT THERE WAS LITTLE IMPROVEMENT IN CARDIAC FUNCTION. IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) WAS SCHEDULED FOR A LATER DATE. ON (B)(6) 2024, THE PATIENT WAS REPORTEDLY LIVING NORMALLY. THE FOLLOWING DAY, THE PATENT COLLAPSED AT HOME AND EMERGENCY MEDICAL ASSISTANCE WAS REQUIRED. AN ELECTROCARDIOGRAM PERFORMED BY THE EMERGENCY MEDICAL TEAM SHOWED CARDIAC ARREST, RESUSCITATION WAS PERFORMED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL, BUT THE PATIENT DID NOT RESPOND, AND DEATH WAS CONFIRMED. A FATAL ARRHYTHMIA OR HEART FAILURE WAS SUSPECTED AS THE CAUSE OF DEATH, BUT COULD NOT BE CONFIRMED AS THE PATIENT WAS NOT WEARING THE WCD AT THE TIME OF CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999024 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| D