BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 543721 · Received July 6, 2004

    Report

    Report Number
    6000089-2004-00691
    Event Type
    Malfunction
    Date Received
    July 6, 2004
    Date of Event
    June 3, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR # 6000089-2004-00692. IT WAS REPORTED THAT PRIOR TO A DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT SHAFT FRACTURED. THE PHYSICIAN WAS ATTEMPTING TO LOAD THE TAXUS EXPRESS2 8.8% 2.5 MM X 24 MM STENT ONTO THE CHOICE PT J WIRE, WHEN THE PROXIMAL PART OF THE SHAFT FRACTURED. THE PHYSICIAN THEN ATTEMPTED TO LOAD A TAXUS EXPRESS2 8.8% 3.0 MM X 16 MM STENT ONTO THE SAME WIRE WHEN THE SHAFT PROXIMAL AND DISTAL TO THE STENT FRACTURED. THE PHYSICIAN BELIEVES THAT THE WIRE WAS NOT COATED WITH THE HYDROPHILIC COATING. THE PHYSICIAN CLAIMED THE WIRE SURFACE WAS NOT SMOOTH. THE DEVICES NEVER ENTERED THE PT, THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.00 X 16 MM 5835850

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR