BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 725134 · Received June 9, 2006

    Report

    Report Number
    6000093-2006-01075
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SOURCE CONFIRMED THAT THE PRODUCT HAD BEEN DISPOSED AND NO ANALYSIS WAS POSSIBLE. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8232713 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE MID RIGHT CORONARY ARTERY (RCA) WAS PRE-DILATED WITH A 3.0X15MM QUANTUM BALLOON. A 3.00X20MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS UNABLE TO CROSS A PREVIOUSLY IMPLANTED TAXUS STENT WHEN IT WAS NOTICED THAT THE STENT STRUTS WERE BENT.. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00X20MM TAXUS STENT. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.00X20MM 8232713

    Patients

    Seq Age Sex Outcome Treatment
    1 YR