BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 3023727 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01784
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 24, 2011
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID#: 2134265-2013-01781, 2134265-2013-01782, 2134265-2013-01783. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD MYOCARDIAL INFARCTION (MI). IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASS-3) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) AND EXTENDING TO THE MID LAD WITH 90% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING TAXUS ELEMENT STENTS OF SIZE 2.50X20MM AND 3.00X32MM, WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS LOCATED IN THE RAMUS INTERMEDIUS WITH 95% STENOSIS AND WAS 24MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING 2.50X20MM TAXUS ELEMENT STENTS, WITH 0% RESIDUAL STENOSIS. ONE DAY POST INDEX PROCEDURE, ELEVATED CARDIAC ENZYME VALUES WERE NOTED AND AN EVENT OF MI WAS REPORTED. THE PATIENT WAS FREE OF SYMPTOMS. THE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125893 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902520250 13705264

    Patients

    Seq Age Sex Outcome Treatment
    1 Other