BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3792016 · Received May 6, 2014

    Report

    Report Number
    2134265-2014-02406
    Event Type
    Death
    Date Received
    May 6, 2014
    Date of Event
    December 13, 2013
    Report Date
    April 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2014-02403, 2134265-2014-02404 2134265-2014-02405. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT DEATH OCCURRED. ON (B)(6) 2013, SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 20 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS A DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL (OM) WITH 95% STENOSIS AND WAS 17 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 20 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 3 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 95% STENOSIS AND WAS 9 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 12 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0 %.TARGET LESION # 4 WAS A DE NOVO LESION LOCATED IN THE 2ND OM WITH 99% STENOSIS AND WAS 13 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS THEN TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 MM X 16 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THREE DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2013, THE SUBJECT DIED OF AN UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270227 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416220 0015780857

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death