BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 25162846 · Received May 13, 2026

    Report

    Report Number
    2124215-2026-25866
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: AS THE EVENT DATE WAS NOT REPORTED, THE FIRST DAY IN THE MONTH OF THE AWARE DATE IS 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. JA2604205069-001 OE27-8, NOVEL DEVICE SUCCESS ALGORITHM OF THE EAPCI PROSPECTIVELY APPLIED TO THE THREE VESSEL DISEASE POPULATION: INSIGHTS FROM THE MULTIVESSEL TALENT TRIAL

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VIA LITERATURE ARTICLE THAT PATIENT COMPLICATION OCCURRED. THE EUROPEAN ASSOCIATION OF PERCUTANEOUS CARDIOVASCULAR INTERVENTIONS (EAPCI) PROPOSED A FIVE STEP ALGORITHM TO DEFINE DEVICE SUCCESS. THIS ALGORITHM HAS BEEN PROSPECTIVELY APPLIED IN THE ONGOING MULTIVESSEL TALENT TRIAL (NCT04390672), WHICH COMPARES NON-BOSTON SCIENTIFIC AND SYNERGY (BOSTON SCIENTIFIC) DRUG ELUTING STENTS IN PATIENTS WITH DE NOVO THREE VESSEL DISEASE. IN ADDITION TO THE FIVE STEP EAPCI DEVICE SUCCESS ALGORITHM, THE CORE LABORATORY INTRODUCED A SIXTH STEP INCORPORATING PHYSIOLOGICAL ASSESSMENT USING QUANTITATIVE FLOW RATIO (DELTA QFR LESS THAN 0.05 ACROSS THE IMPLANTED STENT[S]). DEVICE SUCCESS AS REPORTED BY SITE INVESTIGATORS WAS COMPARED WITH CORE LABORATORY ADJUDICATION USING: (1) RESIDUAL IN STENT DIAMETER STENOSIS (DS) BY QUANTITATIVE CORONARY ANGIOGRAPHY (QCA), (2) DELTA QFR ACROSS STENT(S), AND (3) THE COMBINATION OF ANGIOGRAPHIC AND PHYSIOLOGICAL SUCCESS CRITERIA. AMONG 4,063 CORONARY LESIONS, INVESTIGATORS REPORTED DEVICE SUCCESS IN 97.4% OF CASES. CORE LABORATORY ANALYSIS IDENTIFIED DELTA QFR LESS THAN 0.05 IN 93.8% AND RESIDUAL DS LESS THAN 20% BY QCA IN 88.0% OF LESIONS. WHEN BOTH ANGIOGRAPHIC AND PHYSIOLOGICAL CRITERIA WERE COMBINED, DEVICE SUCCESS WAS OBSERVED IN 83.2% OF LESIONS. SIGNIFICANT DIFFERENCES WERE NOTED BETWEEN SITE REPORTED AND CORE LABORATORY ADJUDICATED SUCCESS RATES. NO SIGNIFICANT DIFFERENCES WERE OBSERVED BETWEEN STENTS, IRRESPECTIVE OF THE SUCCESS DEFINITION USED. ONE YEAR CLINICAL OUTCOMES COMPARING SUCCESSFUL VERSUS UNSUCCESSFUL LESIONS WILL BE REPORTED AT JCS 2026. DESPITE CONTEMPORARY DRUG ELUTING STENT TRIALS DEMONSTRATING LONG TERM EVENT FREE SURVIVAL RATES OF 92 TO 95%, IMMEDIATE DEVICE SUCCESS ADJUDICATED BY THE CORE LABORATORY USING A NOVEL SIX STEP ALGORITHM WAS ACHIEVED IN ONLY 83.2% OF LESIONS. THESE FINDINGS UNDERSCORE THE IMPORTANCE OF STANDARDIZED DOCUMENTATION INCORPORATING BOTH ANATOMICAL AND PHYSIOLOGICAL MEASURES OF PROCEDURAL SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611162 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1