BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 5034636 · Received August 27, 2015

    Report

    Report Number
    2134265-2015-05669
    Event Type
    Death
    Date Received
    August 27, 2015
    Date of Event
    May 9, 2013
    Report Date
    July 30, 2015
    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

    INITIAL REPORTER PHONE: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2010, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. DURING THE INDEX PROCEDURE, THE PATIENT HAD ELEVATED TROPONIN INDICATING A NON Q-WAVE MYOCARDIAL INFARCTION (MI). THE TARGET LESION WAS A DE-NOVO LONG LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING INTO THE MID RCA WITH 95% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00X28MM PROMUS ELEMENT STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TWO DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT EXPIRED DUE TO NATURAL CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568580 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 13591871

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death