BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3981109 · Received August 5, 2014

    Report

    Report Number
    2134265-2014-04580
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    August 9, 2013
    Report Date
    July 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. 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 MYOCARDIAL INFARCTION (MI), CHEST PAIN, AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO STABLE ANGINA, WAS DIAGNOSED WITH MI AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE THEN PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE 2ND OBTUSE MARGINAL (OM) WITH 80% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED PRE-DILATATION AND PLACEMENT OF A 3.00 X 8 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. EIGHT DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH (SOB), CHEST PAIN, BLOOD LOSS AND ACUTE MI AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE ELECTROCARDIOGRAM (ECG) REVEALED LATERAL T WAVE ABNORMALITY. ELEVATED CARDIAC ENZYME VALUES DOES NOT MEET PROTOCOL DEFINITION OF MI. CORONARY ANGIOGRAPHY REVEALED LEFT CIRCUMFLEX (LCX) HAD TOTAL PROXIMAL OBSTRUCTION AND 99% ISR OF STUDY STENT IN SECOND OM. SUBSEQUENTLY, ISR WAS TREATED WITH PLACEMENT OF 2.75 X 8 MM NON BSC STENT, WITH 0% RESIDUAL STENOSIS. THE 70% OSTIAL STENOSIS LOCATED IN PROXIMAL SEGMENT OF SVG TO SECOND OM WAS TREATED WITH BALLOON ANGIOPLASTY AND WITH PLACEMENT OF 4 X 15 MM NON BSC STENT, WITH 0% RESIDUAL STENOSIS. SEVEN DAYS POST PROCEDURE, THE PATIENT THE EVENTS WERE CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457451 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911408300 14991355

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R