BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY XD

    MDR report key: 18387773 · Received December 22, 2023

    Report

    Report Number
    2124215-2023-69614
    Event Type
    Death
    Date Received
    December 22, 2023
    Date of Event
    December 4, 2023
    Report Date
    December 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED WITH CO-MORBIDITIES OF EXTREMELY CALCIFIED VESSELS. THE LESION BEING TREATED WAS THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS INTRAVASCULAR ULTRASOUND (IVUS) IMAGING WAS UTILIZED TO ENSURE THE CORRECT SIZING AND STRATEGY IN APPROACHING TREATMENT OF THE LESION. FOLLOWING ORBITAL ATHERECTOMY TO PREPARE THE SEVERELY CALCIFIED VESSEL, IVUS IMAGING WAS PERFORMED FOLLOWED BY A 10MM X 2.5MM WOLVERINE CUTTING BALLOON CATHETER TO FURTHER PREPARE THE VESSEL PRIOR STENTING THE LAD. A 3.00 X 24MM AND A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENTS WERE DEPLOYED IN THE PROXIMAL AND MID LAD SUCCESSFULLY. POST-DILATATION WAS THEN PERFORMED USING A 3.00MM X 15MM AND A 2.50MM X 12MM NC EMERGE BALLOON CATHETERS. AFTER A SECOND RUN OF IVUS IMAGING AND CONFIRMATION OF STENT EXPANSION, THE PROCEDURE WAS DEEMED SUCCESSFULLY COMPLETED. AFTER THE PROCEDURE, THE PATIENT STATUS WAS INITIALLY GOOD, AND THE PATIENT WAS TAKEN BACK TO THE RECOVERY WARD. HOWEVER, 15 MINUTES LATER, THE PATIENT'S HEALTH DECLINED AND WAS BROUGHT BACK TO THE PROCEDURE ROOM TO INVESTIGATE THE CAUSE. AN ATTEMPT TO RE-WIRE THE ORIGINAL LESION WAS UNSUCCESSFUL AS THE PATIENT HEALTH CONTINUED TO DECLINE. THE PATIENT CRASHED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED, HOWEVER UNSUCCESSFUL, AND THE PATIENT PASSED AWAY. THE OFFICIAL CAUSE OF DEATH WAS POST-PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609482 SYNERGY XD CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 0030247309

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death