BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 879973 · Received September 20, 2006

    Report

    Report Number
    6000089-2006-02078
    Event Type
    Malfunction
    Date Received
    September 20, 2006
    Date of Event
    August 31, 2006
    Report Date
    August 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH # 8685570 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

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PHYSICIAN TRIED TO DELIVER A 2.50X20MM TAXUS EXPRESS2 EIGHT TIMES TO THE DIAGONAL BRANCH. THE PHYSICIAN THEN REMOVED THE DEVICE NOTICED FLARED STENT STRUTS. THIS DEVICE WAS DISPOSED, AND IT WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS OR INJURIES REPORTED. THE PT STATUS IS LISTED AS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.50X20MM 8685570

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR