BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 869069 · Received June 21, 2007

    Report

    Report Number
    6000089-2007-00852
    Event Type
    Injury
    Date Received
    June 21, 2007
    Date of Event
    May 22, 2007
    Report Date
    May 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH # 8894302 SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF ITS RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    SAME PATIENT AS MFR# 6000089-2007-00851 AND 6000089-2007-00853. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE IN-STENT RESTENOSIS OCCURRED. A 3.0X28MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS USED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). IN-STENT RESTENOSIS WAS EXPERIENCED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.0X28MM 8894302

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other