BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS¿ LIBERTÉ¿

    MDR report key: 2882664 · Received December 20, 2012

    Report

    Report Number
    2134265-2012-08029
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 13, 2012
    Report Date
    December 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) AND STENT WITH NO OTHER DEVICES. THERE WAS 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 CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THERE WERE MULTIPLE STENT STRUTS STRETCHED AND BENT IN THE FIRST PROXIMAL ROW. THERE WAS DISTAL TIP DAMAGE. MAGNIFIED INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES. 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 DEVICE ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENT WAS UNABLE TO CROSS LESION. ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 80% STENOSED DE NOVO, CONCENTRIC LESION WAS LOCATED IN A NON-CALCIFIED, SEVERELY TORTUOUS LEFT INTERNAL MAMMARY ARTERY (LIMA). THE LESION WAS 20 MM LONG, HAD A REFERENCE VESSEL DIAMETER OF 2.5 MM, AND A BEND OF <=45 DEGREES. USING A WISEGUIDE GUIDE CATHETER AND PT2 GUIDEWIRE, THE LESION WAS PRE-DIALATED USING A 1.5 X15 MM MAVERICK BALLOON CATHETER WITH 60% STENOSIS IMMEDIATELY FOLLOWING PRE-DILATATION. A 2.50 X 20 MM TAXUS LIBERTE STENT DELIVERY SYSTEM WAS ADVANCED BUT UNABLE TO CROSS THE LESION. THE 2.50 X 20 MM TAXUS LIBERTE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. A 3.00 X 15 MM QUANTUM MAVERICK WAS USED FOR POST-DILATATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE STENT MOVED ON THE DELIVERY BALLOON AND STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ LIBERTÉ¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894020250 15001067

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR