BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 790783 · Received November 21, 2006

    Report

    Report Number
    6000089-2006-02464
    Event Type
    Malfunction
    Date Received
    November 21, 2006
    Date of Event
    October 9, 2006
    Report Date
    October 26, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 #7142970 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    SAME AS: 6000089-2006-02466. IT WAS REPORTED BY THE PT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS AND HEART ATTACK OCCURRED. ACCORDING TO THE CUSTOMER, HE HAD A 3.50X12 MM AND 3.50X16 TAXUS EXPRESS2 DRUG-ELUTING STENT PLACED 16 MONTHS PRIOR TO HAVING "A HEART ATTACK THAT AFFECTED THE LEFT CORONARY ARTERY (LCA). ANOTHER TAXUS EXPRESS2 STENT WAS PLACED AT THAT TIME IN THE LEFT CORONARY ARTERY (LCA). DURING THE PROCEDURE HE WAS FOUND TO HAVE BLOCKAGES IN THE 2 TAXUS EXPRESS2 STENTS ORIGINALLY PLACED." NO ADD'L PT COMPLICATIONS WERE REPORTED. THE PHYSICIAN WAS UNABLE TO PROVIDE ADD'L INFO REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.50X12 MM 7142970

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention