BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 856963 · Received October 6, 2006

    Report

    Report Number
    6000089-2006-02213
    Event Type
    Malfunction
    Date Received
    October 6, 2006
    Date of Event
    April 26, 2006
    Report Date
    June 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPO-TUBE APPROXIMATELY 90.4CM DISTAL TO THE STRAIN RELIEF. IT WAS NOTED THAT BOTH SECTIONS OF THE HYPO-TUBE WERE SEVERELY KINKED. AN EXAMINATION OF THE DISTAL SUB ASSEMBLY FOUND THAT THE SUB ASSEMBLY WAS STRETCHED AND THERE IS A LARGE VOLUME OF SOLIDIFIED CONTRAST MEDIA PRESENT INSIDE THE BALLOON AND THE INFLATION LUMEN OF THE DEVICE. MICROSCOPIC EXAMINATION OF THE BREAK SITE FOUND THAT THE BREAK OCCURRED AS A RESULT OF A SEVERE KINK THAT DEVELOPED IN THE HYPO-TUBE. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH #8141731 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION. 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 9/18/2006. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PRODUCT WAS DEFECTIVE. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT A SHAFT FRACTURE OCCURRED. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 2.75X32MM DRUG ELUTING STENT TO AN UNKNOWN VESSEL. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75X32MM 8416960

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR