BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 22736417 · Received August 7, 2025

    Report

    Report Number
    2124215-2025-54991
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: ESTIMATED BASED ON AWARE DATE AS THE ACTUAL DATE WAS NOT PROVIDED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. INFORMATION WAS OBTAINED AT THE 33RD ANNUAL MEETING OF THE JAPANESE SOCIETY FOR CARDIOVASCULAR INTERVENTION AND TREATMENT IN 2025. ONE-MONTH DUAL ANTIPLATELET THERAPY (DAPT) IS CONSIDERED APPROPRIATE FOR PATIENTS WITH HIGH BLEEDING RISK (HBR), BUT IT WAS UNCLEAR WHETHER A 1-MONTH DAPT IS APPLICABLE TO ALL PATIENTS WITH OR WITHOUT HBR. THE PURPOSE OF THIS STUDY IS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF P2Y12 INHIBITOR MONOTHERAPY AFTER 1-MONTH DAPT. DATA FROM ONE PCI CENTER AND NINE HOSPITALS IN NORTHERN JAPAN WERE USED. THE SUBJECTS WERE 1,202 PATIENTS WHO SUCCESSFULLY UNDERWENT PERCUTANEOUS CORONARY ANGIOPLASTY (PCI) USING A BIODEGRADABLE POLYMER DRUG ELUTING STENTS (DES) (SYNERGY: 400 CASES, NON-BOSTON SCIENTIFIC (NON-BSC): 401 CASES, NON-BSC: 401 CASES). DAPT FOR 1 MONTH WAS APPLIED IN ALL CASES, FOLLOWED BY A P2Y12 INHIBITOR (PRASUGREL 3.75 MG/DAY OR CLOPIDOGREL 75 MG/DAY) MONOTHERAPY. THE PRIMARY ENDPOINT (COMBINED CARDIOVASCULAR AND BLEEDING EVENTS) OCCURRED IN 12 MONTHS, WHICH WAS SIGNIFICANTLY BELOW THE PRE-SPECIFIED NON-INFERIORITY TARGET VALUE. THERE WAS ONLY ONE CASE OF STENT THROMBOSIS, WHICH OCCURRED ON THE 258TH DAY. THERE WERE 6 CASES OF STROKE AND 22 CASES OF DEATH. IT WAS SUGGESTED THAT THE TREATMENT STRATEGY OF PERFORMING P2Y12 INHIBITOR MONOTHERAPY AFTER 1-MONTH DAPT IS SAFE FOR BOTH HBR PATIENTS AND NON-HBR PATIENTS IN DAILY MEDICAL CARE. IT COULD NOT BE COMPARED DIRECTLY WITH THE LONG-TERM DAPT BECAUSE IT IS A SINGLE-GROUP DESIGN, BUT THE CLINICAL SIGNIFICANCE OF THIS STRATEGY WAS SHOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2121578 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other