BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 3813599 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02676
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    November 13, 2013
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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: 2134265-2014-00932, 2134265-2014-00836, 2134265-2014-00837, 2134265-2014-02674, 2134265-2014-02675. (B)(4). IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2012, A 2.5 X 8 MM ION DRUG ELUTING STENT WAS IMPLANTED IN THE FIRST OBTUSE MARGINAL (OM) BRANCH, FOLLOWED BY A 2.5X16MM PROMUS ELEMENT PLUS STENT WHICH WAS IMPLANTED IN (B)(6) 2012 AND A 2.25X16MM PROMUS ELEMENT PLUS STENT WHICH WAS IMPLANTED IN (B)(6) 2012. IN (B)(6) 2013, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 75-80%% DIFFUSE RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENTS (2.5 X 8 MM ION STENT, 2.5 X 16 MM PROMUS ELEMENT PLUS STENT AND 2.25 X 16 MM PLUS ELEMENT PLUS STENT) LOCATED IN THE 1ST OM. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.25MM X 28 MM UNSPECIFIED DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS. THE EVENT ACCELERATED ANGINA WAS CONSIDERED NOT RECOVERED/NOT RESOLVED AND THE EVENT CHEST PAIN AND IN-STENT RESTENOSIS WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290288 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention