BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 17871677 · Received October 4, 2023

    Report

    Report Number
    2124215-2023-52648
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 1, 2023
    Report Date
    October 4, 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 ADDRESS 1: (B)(6).

    Description of Event or Problem · 0

    SYNERGY CHINA REGISTRY. IT WAS REPORTED THAT ANGINA OCCURRED. IN (B)(6) 2022, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO DISTAL RCA WITH 95% STENOSIS AND WAS 70 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY THE PLACEMENT OF A 3.00 MM X 38 MM SYNERGY STENT SYSTEM. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2023, 270 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH STABLE ANGINA PECTORIS AND WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION AND TREATMENT. THE NEXT DAY, THE SUBJECT WAS ALSO DIAGNOSED WITH IMPAIRED GLUCOSE TOLERANCE. NO ACTION WAS TAKEN TO TREAT THE EVENT. FOUR DAYS AFTER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. BOTH THE EVENTS WERE CONSIDERED TO BE RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201248 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10623 0028111573

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other