BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2962496 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00592
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED IN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, ANGINA AND RESTENOSIS OCCURRED. IN MAY 2012, THE PATIENT PRESENTED DUE TO CHEST PAIN AND PRESSURE IN CHEST RADIATING TO ARMS/SHOULDERS WHICH WAS DIAGNOSED AS STABLE ANGINA (CCS CLASSIFICATION-3) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 80% STENOSED, 28 X 4MM TARGET LESION WAS A DE NOVO LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 4.00 MM X 28 MM PE PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED THE NEXT DAY. IN JANUARY 2013, THE PATIENT PRESENTED WITH ATYPICAL CHEST PAIN WITH PROGRESSIVE LEFT SHOULDER AND SCAPULAR PAIN RADIATING TO SCAPULA AND WAS HOSPITALIZED ON THE SAME DAY. CORONARY ANGIOGRAPHY WAS RECOMMENDED. THE 80% STENOSIS IN THE PROXIMAL (RCA) EXTENDING INTO THE STUDY STENT WAS TREATED WITH PLACEMENT OF A 3.5 MM X 12 MM TAXUS DRUG ELUTING STENT, WITH 0% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED TO BE RECOVERING/RESOLVING AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65438 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428400 0014677041

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R