BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 6980305 · Received October 26, 2017

    Report

    Report Number
    2134265-2017-10388
    Event Type
    Injury
    Date Received
    October 26, 2017
    Report Date
    September 29, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. LITERATURE CITATION: NOAD RL, ET. AL. ¿INITIAL EXPERIENCE OF BIOABSORBABLE POLYMER EVEROLIMUS-ELUTING SYNERGY STENTS IN HIGH-RISK PATIENTS UNDERGOING COMPLEX PERCUTANEOUS CORONARY INTERVENTION WITH EARLY DISCONTINUATION OF DUAL-ANTIPLATELET THERAPY¿. J INVASIVE CARDIOL. 2017; 29 (2): 36-41. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED TO THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME LITERATURE ARTICLE AS MDR ID: 2134265-2017-10385, 2134265-2017-10387, 2134265-2017-10386 AND 2134265-2017-10367. IT WAS REPORTED VIA LITERATURE THAT TARGET VESSEL REVASCULARIZATION (TVR) OCCURRED. THIS STUDY ASSESSED PATIENTS WHO UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH A SYNERGY STENT TO EXAMINE A MINIMUM OF 6 MONTHS OF CLINICAL OUTCOMES AFTER EARLY DISCONTINUATION OF DUAL ANTIPLATELET THERAPY (DAPT). STENTING INVOLVED LEFT MAIN STEM, MULTIVESSEL DISEASE AND CHRONIC TOTAL OCCLUSION LESIONS. POST DAPT DISCONTINUATION THERE WAS ONE PATIENT DEATH DUE TO HEART FAILURE, 3 TVR¿S WITH PCI AND ONE PATIENT WITH IN-STENT RESTENOSIS TREATED WITH CORONARY ARTERY BYPASS GRAFT SURGERY. THERE WAS NO STENT THROMBOSIS OR MYOCARDIAL INFARCTION. IN CONCLUSION THE LITERATURE INDICATED THAT USE OF THE SYNERGY EVEROLIMUS-ELUTING STENT ALLOWS FOR EARLY DISCONTINUATION OF DAPT, REDUCING RISK OF BLEEDING COMPLICATIONS AND FACILITATING NON-CARDIAC PROCEDURES, WITHOUT AN INCREASE IN STENT THROMBOSIS AND WITH EXCELLENT RESULTS FOR TVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758344 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK744

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention