BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2221498 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03424
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    May 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE RETURNED DEVICE CONSISTED OF A TAXUS LIBERTE MONORAIL STENT DELIVERY SYSTEM (SDS). THERE WAS BLOOD AND CONTRAST IN THE INFLATION LUMEN. THE STENT HAD MOVED ON THE BALLOON 1MM DISTALLY FROM THE PROXIMAL MARKERBAND AND THERE WERE STENT STRUT IMPRESSIONS PRESENT ON THE SURFACE OF THE BALLOON BETWEEN THE MARKER BANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE STENT WAS DAMAGED WITH THE FIRST TWO DISTAL ROWS OF STRUTS STRETCHED AND FLARED. THERE WAS TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CROSSING DIFFICULTY. 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

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED AND THEN A 3.0X28MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO CROSS THE SDS SEVERAL TIMES AND RE-DILATED THE LESION BUT THE DEVICE WAS STILL UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED THAT THE STENT WAS DAMAGED AND HAD MOVED ON THE BALLOON.

    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 H7493894028300 13820171

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR