BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 6088315 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-10087
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)((4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. (B)((4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2016-10085, 2134265-2016-10086. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THE PATIENT DIED. THE PATIENT HAD THREE SYNERGY STENTS IMPLANTED AND WAS DISCHARGED. ON THE WAY HOME FOLLOWING HOSPITAL DISCHARGE, THE PATIENT EXPERIENCED ANOTHER "HEART ATTACK" AND DIED. THE PHYSICIAN MENTIONED TO THE PATIENT'S FAMILY THAT ONE OF THE SYNERGY STENTS "COLLAPSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741308 SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC - GALWAY H7493926028250 0018611889

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death