BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 4213155 · Received October 30, 2014

    Report

    Report Number
    2134265-2014-06512
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 14, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT CHEST PAIN AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN AND A 2.25X20MM PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS IMPLANTED IN THIRD DIAGONAL. IN (B)(6) 2014, THE PATIENT PRESENTED WITH TWO DAY HISTORY OF RECURRENT REST CHEST DISCOMFORT ASSOCIATED WITH BILATERAL AXILLARY DISCOMFORT, SHORTNESS OF BREATH AND PROGRESSIVE FATIGUE. FOUR DAYS LATER, THE PATIENT RETURNED TO THE FACILITY FOR THE SCHEDULED PROCEDURE AND WAS DIAGNOSED WITH CARDIAC CHEST PAIN. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY AND CARDIAC CATHETERIZATION WAS RECOMMENDED. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG WAS LAST TAKEN IN 2011. CORONARY ANGIOGRAPHY REVEALED 75% STENOSIS IN LEFT MAIN CORONARY ARTERY (LMCA), 90 % STENOSIS IN SECOND DIAGONAL AND 90 % ISR OF THE PREVIOUSLY PLACED 2.25 X 20 MM PROMUS ELEMENT PLUS STENT. ON THE FOLLOWING DAY, THE PHYSICIAN TREATED THE LESIONS WITH CORONARY ARTERY BYPASS GRAFTING (CABG) FROM LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LEFT ANTERIOR DESCENDING (LAD); REVERSE SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL (OM) AND RIGHT POSTERIOR DESCENDING ARTERY (R-PDA); REVERSE SVG TO 2ND DIAGONAL AND REVERSE SVG TO 3RD DIAGONAL RESPECTIVELY. FOLLOWING POST-DILATATION, RESIDUAL STENOSS WAS 0%. POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697225 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 66 YR Hospitalization| R