BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6036838 · Received October 18, 2016

    Report

    Report Number
    2134265-2016-09133
    Event Type
    Death
    Date Received
    October 18, 2016
    Date of Event
    June 21, 2012
    Report Date
    September 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED TO THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID 2134265-2016-09134. (B)(6) CLINICAL TRIAL. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AS PER PE PROVE PROTOCOL. TARGET LESION 1 WAS AN 80% STENOSED DE-NOVO LESION LOCATED IN THE 3RD OBTUSE MARGINAL (OM). THE LESION WAS PRE-DILATED AND A 2.50X28MM PROMUS ELEMENT STENT WAS DEPLOYED. RESIDUAL STENOSIS WAS 0%. TARGET LESION 2 WAS A 90% STENOSED DE-NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX). THE LESION WAS PRE-DILATED AND A 3.00X12MM PROMUS ELEMENT STENT WAS DEPLOYED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. A YEAR AND A HALF LATER THE PATIENT DIED. THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688464 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 Death