BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2193233 · Received August 5, 2011

    Report

    Report Number
    2134265-2011-03447
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). 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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION OCCURRED. THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASS2). CARDIAC CATHETERIZATION REVEALED A 90% STENOSED AND 18MM LONG LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.75X20MM TAXUS ELEMENT STENT RESULTING IN 0% RESIDUAL STENOSIS. THE SAME DAY POST PROCEDURE, THE PATIENT WAS FOUND TO HAVE ELEVATED CARDIAC ENZYMES (PEAK TROPONIN= 1.4 MCG/L, ULN= 0.2 MCG/L, PEAK CKMB= 7.8 MCG/L, ULN= 3.1 MCG/L) AND WAS DIAGNOSED AS HAVING A MYOCARDIAL INFARCTION. NO ACTION WAS TAKEN TO TREAT THIS EVENT AND IT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 1 DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902520270 14310289

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other