BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNERGY¿

    MDR report key: 4912302 · Received July 14, 2015

    Report

    Report Number
    2134265-2015-04492
    Event Type
    Death
    Date Received
    July 14, 2015
    Date of Event
    June 13, 2015
    Report Date
    June 18, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2015-04491, 2134265-2015-04494, AND 2134265-2015-04495. IT WAS REPORTED THAT DEATH OCCURRED. A 38X3.00MM, 20X3.50MM AND 20X3.00MM SYNERGY¿ STENTS AND A 2.75X28MM PROMUS ELEMENT ¿ STENT WERE IMPLANTED IN RIGHT CORONARY ARTERY (RCA) AND CIRCUMFLEX ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, ON THE NIGHT POST PROCEDURE, THE PATIENT DEVELOPED RETROPERITONEAL HEMATOMA AND THE PATIENT DIED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE CAUSE OF DEATH IS UNKNOWN AND AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455184 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493919820350 16942826

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death