BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 3002638 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01403
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    August 20, 2012
    Report Date
    February 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF BIRTH: 1939. DEVICE IS COMBINATION PRODUCT. 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) STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE FIRST TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY INTO THE MID LEFT ANTERIOR DESCENDING ARTERY AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.50 MM X 16 MM TAXUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. THE SECOND, 90% STENOSED, 15 X 2.5MM TARGET LESION WAS A DE NOVO LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE 1ST DIAGONAL BRANCH. THE SECOND TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.50 MM X 12 MM TAXUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN AUGUST 2012, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS HOSPITALIZED. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED 90-99% FOCAL IN-STENT RESTENOSIS OF THE STUDY STENT LOCATED IN THE SVG TO THE 1ST DIAGONAL BRANCH. A 3.0 X 32 MM PROMUS ELEMENT STENT WAS INTRODUCED AND WAS UNABLE TO CROSS THE LESION. A 3.0 X 30 MM NON-BSC DRUG ELUTING STENT WAS THEN USED TO TREAT THE STENOSIS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS ON THE SAME DAY AND THE PATIENT WAS DISCHARGED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105298 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902512250 13559971

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R