BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 7426885 · Received April 12, 2018

    Report

    Report Number
    2134265-2018-03130
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    February 28, 2017
    Report Date
    March 21, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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.: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS ANTICIPATED PROCEDURAL COMPLICATION AS THE EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH MI AND UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS 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. X-RAY REVEALED STABLE CARDIOMEGALY WITH MILD CENTRAL PULMONARY VENOUS CONGESTION. ELECTROCARDIOGRAM REVEALED SINUS RHYTHM WITH FREQUENT PREMATURE VENTRICULAR COMPLEXES AND A RIGHT BUNDLE BRANCH BLOCK. TROPONIN VALUES WERE NOTED TO BE ELEVATED AND SITE REPORTED AN EVENT OF MI. THE PATIENT RECEIVED MEDICATION THERAPY IN RESPONSE TO THE EVENT. TWO DAYS LATER, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2018-05398 IT WAS FURTHER REPORTED THAT IN (B)(6) 2017, 80% DISCRETE IN-STENT STENOSIS IN MID RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH PREDILATATION AND PLACEMENT OF 3.5 X 23 NON-BSC STENT. FOLLOWING POST DILATATION THE RESIDUAL STENOSIS WAS 0%. ADDITIONALLY, THE PATIENT RECEIVED MEDICATION THERAPY IN RESPONSE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269307 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911424300 15084446

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R