BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1811614 · Received August 23, 2010

    Report

    Report Number
    2134265-2010-03514
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM (SDS). BLOOD AND CONTRAST WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. THE SDS WITH STENT WAS VISUALLY, TACTILELY AND MICROSCOPICALLY EXAMINED ALONG THE ENTIRE LENGTH AND THE ONLY DAMAGE SEEN ON THE DEVICE WAS PROXIMAL STENT DAMAGE AND TIP DAMAGE. THE STENT HAD THE FIRST FOUR ROWS OF STRUTS AT THE PROXIMAL END DAMAGED AND EXTENDING BACK UP TO 90 DEGREES. 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 THE ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. THE VASCULAR ACCESS SITE WAS FEMORAL. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION LENGTH WAS 36MM AND THE REFERENCE VESSEL DIAMETER WAS 3.0MM. THE PHYSICIAN DILATED THE LESION WITH AN UNSPECIFIED 2.0X20MM BALLOON AND THEN ATTEMPTED TO CROSS THE LESION SEVERAL TIMES WITH A TAXUS LIBERTE' 3.0X38MM STENT BUT WAS UNSUCCESSFUL. THE STENT DELIVERY SYSTEM WAS WITHDRAWN FROM THE PATIENT. THE LESION WAS DILATED AGAIN AND THEN TWO UNSPECIFIED SHORTER STENTS (3.0X16MM AND 3.0X24MM) WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS REPORTED AS STABLE. HOWEVER, THE RETURNED PRODUCT REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894038300 12991476

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR