BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 771981 · Received August 11, 2006

    Report

    Report Number
    6000089-2006-01668
    Event Type
    Malfunction
    Date Received
    August 11, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS CONFIRMED THE COMPLAINT REPORTED. THE DEVICE APPEARED TO HAVE BEEN KINKED AT THE POINT OF SEPARATION. VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED THAT THE HYPO-TUBE HAD BROKEN APPROX 62 CENTIMETERS DISTAL FROM THE CATHETER'S STRAIN RELIEF. A REVIEW OF THE MFG RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8233949 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS, AT THE TIME OF RELEASE TO DISTRIBUTION. A DETAILED EXAMINATION OF THE RETURNED DEVICE COULD NOT IDENTIFY ANY ISSUE WITH THE ACTUAL DEVICE THAT COULD CAUSE SUCH A BREAK TO OCCUR. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 7/20/06. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, CROSSING INABILITY OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS LIBERTE 2.5X16MM DRUG ELUTING STENT TO THE 85% STENOSED LESION LOCATED IN THE MODERATELY CALCIFIED, SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA), BUT WAS UNABLE TO CROSS THE LESION. UPON WITHDRAWAL OF THE STENT, IT WAS NOTED THAT THE SHAFT HAD KINKED DURING THE PROCEDURE. THE PHYSICIAN THEN COMPLETED THE PROCEDURE WITH ANOTHER TAXUS LIBERTE STENT, SAME SIZE. NO PT INJURIES OR COMPLICATIONS OCCURRED. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT A SHAFT FRACTURE OCCURRED. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.5X16MM 8233949

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR