BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? ELEMENT? LONG

    MDR report key: 3951136 · Received July 22, 2014

    Report

    Report Number
    2134265-2014-04319
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 29, 2014
    Report Date
    June 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES WITH THE PROFILE WITH NO SIGNS OF OVERLAPPING OR RAISED STENT STRUTS. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 30MM IN LENGTH, 90% STENOSED AND CONCENTRIC TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS AND 4MM IN DIAMETER PROXIMAL RIGHT CORONARY ARTERY. A JR 3.5 7F UNSPECIFIED GUIDE CATHETER WAS USED. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED FOR PREDILATION OF THE LESION. THEN A 38MM X 4.00MM TAXUS¿ ELEMENT¿ LONG STENT ADVANCED TO THE LESION, HOWEVER "A LOT" OF RESISTANCE WAS FELT. THE STENT SUDDENLY CROSSED THE LESION AND WENT DISTALLY. THE PHYSICIAN TRIED TO REPEATEDLY PULL THE DEVICE TO COVER THE LESION BUT "A LOT" OF RESISTANCE WAS ALSO ENCOUNTERED. IT WAS THEN NOTICED UNDER FLUOROSCOPY THAT THE STENT WAS DAMAGED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427691 TAXUS? ELEMENT? LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902538400 15818187

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GUIDE WIRE: BMW