BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2873044 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07915
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED. 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 WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR #2134265-2012-07914. (B)(4). IT WAS REPORTED DURING A PERCUTANEOUS CORONARY INTERVENTION THAT MYOCARDIAL INFARCTION OCCURRED. THE SUBJECT PRESENTED DUE TO STABLE ANGINA (CCS CLASS III) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE RAMUS AND WAS DESCRIBED AS 16 MM LONG, WITH A VESSEL DIAMETER OF 2.25 MM AND 70% STENOSIS. THE LESION WAS TREATED WITH DEPLOYMENT OF A PROMUS ELEMENT PLUS STENT 2.25X20 MM WITH 0% RESIDUAL STENOSIS. THE SECOND TARGET LESION LOCATED IN THE MID LAD (LEFT ANTERIOR DESCENDING ARTERY) WAS DESCRIBED AS 10 MM LONG, WITH A VESSEL DIAMETER OF 3.20MM AND 70% STENOSIS. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50X16MM PROMUS ELEMENT PLUS STENT WITH 0% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, THE SUBJECT EXPERIENCED A MYOCARDIAL INFARCTION. CARDIAC ENZYME LEVELS WERE NOTED TO BE ELEVATED POST-INDEX PROCEDURE. NO ACTION WAS TAKEN, THE PATIENT RECOVERED AND THE EVENT WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416350 15068599

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other