BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6181573 · Received December 16, 2016

    Report

    Report Number
    2134265-2016-11742
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    UDI-DI
    08714729840077
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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

    (B)(6) STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2016, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 75% STENOSIS AND WAS A 9MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4MM. THE LESION WAS TREATED WITH PLACEMENT OF A 4.00X12MM SYNERGY II STENT WITH 0% RESIDUAL STENOSIS. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2016, THE PATIENT HAD BEEN HAVING TROUBLE WITH HYPOGLYCEMIA AND EXPIRED AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832860 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926012400 18451569 08714729840077

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death