BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1771662 · Received July 27, 2010

    Report

    Report Number
    2134265-2010-03142
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL AND MICROSCOPIC EXAMINATION REVEALED THAT THE STRUTS ON ROWS 1 TO 5 FROM THE DISTAL EDGE WERE MISALIGNED AND PUSHED 2MM OF THE DISTAL MARKERBAND. THE STRUTS ON ROWS 1 AND 2 FROM THE PROXIMAL EDGE WERE RAISED. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. THE LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED THE 2.75X38MM TAXUS LIBERTE STENT TO THE LESION, BUT WAS UNABLE TO CROSS. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X38MM TAXUS LIBERTE STENT. PATIENT STATUS IS REPORTED AS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS 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 - GALWAY H7493894038270 12701867

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR