BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1984125 · Received February 10, 2011

    Report

    Report Number
    2134265-2011-00146
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    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: THE TAXUS LIBERTE (MR) STENT DELIVERY SYSTEM (SDS) WAS RETURNED. CONTRAST AND BLOOD WERE VISIBLE IN THE DISTAL AND MIDSHAFT OF THE DEVICE WHICH IS CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS USED. IT WAS DETERMINED THAT THE FIRST DISTAL ROW OF STRUTS WERE FLARED OUT UP TO 45 DEGREES. THE UNDAMAGED PORTION OF THE RETURNED STENT MEETS THE APPLICABLE SPECIFICATION FOR OUTER DIAMETER. THE MANUFACTURING BATCH RECORD REVIEW FOR THE REPORTED BATCH CONFIRMED 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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE WAS NOTED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERLY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. AFTER ROTABLATOR ABLATION WITH 1.75MM ROTABLATOR, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 3X12MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) SEVERAL TIMES, BUT THE SDS DID NOT CROSS THE LESION. THE SDS WAS REMOVED OUTSIDE THE BODY AND IT WAS NOTED THAT THE STENT STRUT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS LISTED AS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE WAS NOTED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERLY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. AFTER ROTABLATOR ABLATION WITH 1.75MM ROTABLATOR, THE PHYSICIAN ATTEMPTED TO ADVANCE THE 3X12MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) SEVERAL TIMES, BUT THE SDS DID NOT CROSS THE LESION. THE SDS WAS REMOVED OUTSIDE THE BODY AND IT WAS NOTED THAT THE STENT STRUT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS LISTED AS GOOD.

    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 H7493893612300 12923052

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTABLATOR 1.75MM