BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 6118662 · Received November 21, 2016

    Report

    Report Number
    2134265-2016-10347
    Event Type
    Death
    Date Received
    November 21, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH DATE: (B)(6) 2016. EVENT DATE: (B)(6) 2016. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED 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

    SAME CASE AS MFR ID: 2134265-2016-10346. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2014, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. ON THE SAME DAY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A BIFURCATED AT PROXIMAL LEFT ANTERIOR DESCENDING (LAD) TO FIRST DIAGONAL WITH 90% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE BIFURCATION AT THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING KISSING BALLOON TECHNIQUE FOLLOWED BY PLACEMENT OF OVERLAPPING 2.50X20MM AND 2.50X28MM PROMUS ELEMENT ¿ DRUG-ELUTING STENTS. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS 0%. FOUR DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT DIED. CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767504 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 0016855920

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death