BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 17402796 · Received July 27, 2023

    Report

    Report Number
    2124215-2023-38543
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    March 31, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER: FACILITY NAME: TONG REN HOSPITAL SHANGHAI JIAOTONG UNIVERSITY SCHOOL OF MEDICINE.

    Description of Event or Problem · 0

    SYNERGY CHINA REGISTRY IT WAS REPORTED THAT UNSTABLE ANGINA OCCURRED. IN ( B)(6)2022, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND EXTENDING UP TO DISTAL LAD WITH 70% STENOSIS WITH UNKNOWN MM OF LENGTH AND A REFERENCE VESSEL DIAMETER OF UNKNOWN MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.50 MM X 20 MM SYNERGY STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 0%. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2023, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA PECTORIS AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. EIGHT DAYS LATER, IN (B)(6) 2023, THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RECOVERING/RESOLVING. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662614 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10619 0029583817

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization