BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 782323 · Received November 15, 2006

    Report

    Report Number
    6000089-2006-02423
    Event Type
    Injury
    Date Received
    November 15, 2006
    Date of Event
    September 19, 2006
    Report Date
    October 17, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    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 RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8130426 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE INITIAL PROCEDURE OCCURRED IN 2006 IN WHICH THE PHYSICIAN PLACED A TAXUS EXPRESS2 2.75X20MM DRUG ELUTING STENT TO THE MID CIRCUMFLEX (CX) ARTERY. FIVE MONTHS LATER, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS AND THE PHYSICIAN PLACED ANOTHER TAXUS EXPRESS2 2.75X20MM DRUG ELUTING STENT SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.75X20MM 8130426

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention