BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 789213 · Received November 27, 2006

    Report

    Report Number
    6000089-2006-02485
    Event Type
    Injury
    Date Received
    November 27, 2006
    Report Date
    November 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: 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 MFG RECORDS FOR THIS PARTICULAR BATCH # 8003790 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    SAME CASE AS MDR# 6000093-2006-02451. IT WAS REPORTED BY THE PT THAT 6 MONTHS FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE HE EXPERIENCED COMPLICATIONS. THE CONSUMER REPORTED THAT HE HAD A TAXUS EXPRESS2 DRUG ELUTING STENT IMPLANTED AND ANOTHER TAXUS EXPRESS2 STENT IMPLANTED THREE DAYS LATER. THE STENT SIZES WERE 3.0 X 20MM AND A 3.5 X 8MM. IT IS UNCLEAR WHICH STENT WAS IMPLANTED ON WHICH DATE AND IT IS UNK WHAT VESSEL THE STENTS WERE IMPLANTED. "RHINITIS AND TESTICULAR TENDERNESS WERE NOTICED IN MID-JUNE AND PERSISTING UNTIL MID-JULY." HE WAS HOSPITALIZED WITH "SWELLING OF THROAT AND MUCOSAL TISSUE WITH FLUID BACKING UP TO THE EYES." HE REPORTED THAT HIS "OXYGEN SATURATIONS AT THAT TIME WERE BELOW NORMAL." HE DESCRIBES HIS "TESTICULAR CHANGES BEING TENDERNESS WITH CONTACT TO ANY SURFACE AND THE SKIN BEING FLACCID AND CLAMMY." THE CONSUMER ALSO REPORTED MUSCLE PAIN AND ACHING DURING THIS TIME PERIOD. HE "CONTINUES TO HAVE RHINITIS 24 HRS A DAY AND SINUS INFLAMMATION AND DRAINAGE." THE CONSUMER DISCONTINUED TAKING PLAVIX AND LIPITOR IN SEPTEMBER AND "THE SYMPTOMS HAVE DIMINISHED." ATTEMPTS FOR ADD'L INFO FROM THE PHYSICIAN HAVE BEEN MADE.

    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 3.5 X 8MM 8003790

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other