BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 3812363 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02578
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED AT THE DISTAL END. STRUTS ON THE MOST DISTAL ROW HAD BEEN RAISED VERTICALLY AND BENT TOWARDS THE TIP. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. A 28MM X 2.50MM TAXUS ELEMENT STENT WAS UNABLE TO CROSS THE LESION. ANGIOPLASTY WAS PERFORMED WITH A 2.5X20MM BALLOON CATHETER. THE PHYSICIAN ATTEMPTED TO READVANCE THE 28MM X 2.50MM TAXUS ELEMENT STENT; HOWEVER, THE DEVICE CONTINUED TO BE UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH 3.0X14MM NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS' STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291972 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902528250 16313630

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR