BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY

    MDR report key: 22128632 · Received June 2, 2025

    Report

    Report Number
    2124215-2025-31001
    Event Type
    Death
    Date Received
    June 2, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729841371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER A WELL-VESSEL PREPARATION, A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED IN LAD. SECOND AND THIRD NON-BOSTON SCIENTIFIC STENTS WERE ALSO DEPLOYED RESPECTIVELY IN THE LEFT CIRCUMFLEX ARTERY AND THE RIGHT CORONARY ARTERY. IT WAS NOTED THAT THE PATIENT CONDITION WAS BAD ON THE CARDIAC CATHETERIZATION TABLE. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT. AFTER SOME TIME, THE PATIENT DEVELOPED HYPOTENSION, EXPERIENCED CHEST PAIN, AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS IMMEDIATELY PERFORMED BUT THE PATIENT DIED. THE OFFICIAL CAUSE OF DEATH WAS CARDIAC ARREST, AND AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358451 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10623 0032275121 08714729841371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death