BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 5930801 · Received September 6, 2016

    Report

    Report Number
    2134265-2016-07873
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    July 23, 2016
    Report Date
    August 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FACILITY MEDWATCH 5063713 THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 3.00 X 16 SYNERGY II STENT WAS ADVANCED HOWEVER UPON THE ATTEMPT OF RETRACTING THE STENT INTO THE GUIDE CATHETER, THE STENT DISPLACED. THE PROCEDURE WAS COMPLETED WITH TWO BARE METAL STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581917 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926016300 19128673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention