BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 737224 · Received June 30, 2005

    Report

    Report Number
    6000093-2005-00773
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    June 17, 2005
    Report Date
    June 22, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS DEVICE WAS DISPOSED, AN ANALYSIS COULD NOT BE PERFORMED. THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED AND NO ANALYSIS WAS POSSIBLE. THE SHOP FLOOR PAPERWORK (SFP) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SFP REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE EXACT CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING PREPARATION FOR A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS FOUND. THE PHYSICIAN WAS PREPPING A TAXUS EXPRESS2 3.0X12MM DRUG ELUTING STENT WHEN IT WAS NOTICED THAT A STENT STRUT WAS STICKING UP. THE DAMAGED STENT WAS EXCHANGED FOR ANOTHER TAXUS STENT OF THE SAME SIZE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT COMPLICATIONS WERE REPORTED.

    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 12 MM 7531786

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN