BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 7558012 · Received May 31, 2018

    Report

    Report Number
    2134265-2018-05398
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    February 28, 2017
    Report Date
    May 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2018-03130 (B)(6) STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH MI WITHOUT ST ELEVATION (NSTEMI) AND UNSTABLE ANGINA. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING TO MID RCA WITH 99% STENOSIS AND WAS 30MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.00X24MM AND 3.50X16.00MM PROMUS ELEMENT¿ PLUS STENTS WITH 0% RESIDUAL STENOSIS. AFTER THREE DAYS, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2017, THE PATIENT PRESENTED TO EMERGENCY ROOM WITH COMPLAINTS OF CENTRAL CHEST PAIN. THE PATIENT DESCRIBED THE CHEST PAIN AS A STABBING SENSATION ASSOCIATED WITH DYSPNEA ON EXERTION AND NAUSEA. THE PATIENT ALSO EXPERIENCED FALL AT HOME. SUBSEQUENTLY, PATIENT WAS HOSPITALIZED ON THE SAME DAY FOR FURTHER EVALUATION. IN (B)(6) 2017, 80% DISCRETE IN-STENT STENOSIS IN MID RCA WAS TREATED WITH PREDILATATION AND PLACEMENT OF 3.5 X 23 NON-BSC DRUG-ELUTING STENT. FOLLOWING POST DILATATION THE RESIDUAL STENOSIS WAS 0%. ADDITIONALLY, THE PATIENT RECEIVED MEDICATION THERAPY IN RESPONSE TO THE EVENT. ON THE FOLLOWING DAY, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400534 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416350 0015172721

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R