BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 853669 · Received October 10, 2006

    Report

    Report Number
    6000089-2006-02227
    Event Type
    Malfunction
    Date Received
    October 10, 2006
    Date of Event
    May 8, 2006
    Report Date
    May 9, 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

    VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A SEVERE KINK LOCATED AT APPROX 25.5 CENTIMETERS DISTAL TO THE DISTAL END OF THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND BOTH PROXIMAL AND DISTAL STENT DAMAGE. MICROSCOPIC EXAMINATION OF THE BALLOON FOUND NO ISSUES. THE RECOMMENDED SIZE GUIDEWIRE WAS INSERTED THROUGH THE GUIDEWIRE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE MFG RECORD FOR THIS PARTICULAR BATCH #8000488 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. THE ROOT CAUSE OF THE STENT DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED IN 2006. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THERE WAS DIFFICULTY CROSSING THE LESION. A 2.75X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS ADVANCED TOWARD THE RCA, BUT IT DID NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS EXPRESS2 DRUG ELUTING STENT OF THE SAME SIZE. THERE WERE NO PT COMPLICATIONS. THE PT STATUS IS LISTED AS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75X24MM 8000488

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR