BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1943510 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05667
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 27, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    (B)(4). A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED THAT THE HYPOTUBE WAS BROKEN 72CM FROM THE CATHETER'S STRAIN RELIEF. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT AND A KINK IN THE LUMEN WAS ALSO IDENTIFIED 14CM DISTAL TO THE PORT AREA. THE BALLOON AND STENT 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 POSITIVE PRESSURE. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION 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) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 60% STENOSED CONCENTRIC DE NOVO LESION MEASURING 2.5MM IN DIAMETER AND 2.0MM IN LENGTH WAS LOCATED IN A NON-TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ATTEMPTED TO DIRECT STENT WITH A 3.5X38MM TAXUS LIBERTE' STENT, BUT COULD NOT CROSS THE LESION. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. PRODUCT ANALYSIS REVEALED A HYPOTUBE FRACTURE.

    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 H7493894038350 12900255

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR