BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3193417 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04510
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    February 16, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS), STENT, PROTECTIVE TUBING AND PRODUCT MANDREL. THE PROTECTIVE TUBING WAS ON THE PRODUCT MANDREL. THE PRODUCT MANDREL WAS LOADED THROUGH THE DISTAL TIP AND WAS PARTIALLY IN THE WIRE LUMEN. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THE STENT SECURED ON THE BALLOON. THE PROXIMAL END OF THE STENT WAS STRETCHED AND HAD EXTENDED PAST THE PROXIMAL MARKERBAND. THE DISTAL END OF THE STENT WAS BUNCHED UP AND WAS 6MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THERE WERE STENT IMPRESSIONS ON THE BALLOON INDICATING THE STENT WAS POSITIONED BETWEEN THE MARKERBANDS DURING MANUFACTURING. THE DISTAL TIP WAS STRETCHED AND FROZE ON THE PRODUCT MANDREL. THERE WAS NO EVIDENCE OF ANY DAMAGE OR IRREGULARITIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 ANALYSIS COMPLETED ON (B)(4) 2013.   IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, DIFFICULTY CROSSING THE LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE 32 X 2.75MM TAXUS LIBERTE STENT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.   HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291650 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894032270 15152143

    Patients

    Seq Age Sex Outcome Treatment
    1