BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 969287 · Received December 21, 2007

    Report

    Report Number
    6000089-2007-01732
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    November 22, 2007
    Report Date
    November 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #6000084-2007-00070. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT WAS NOT FULLY DILATED. A TAXUS EXPRESS2 3.0 X 16MM DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND IT WAS NOTED, WITH IVUS, THAT THE STENT WAS NOT FULLY DILATED. WHILE WITHDRAWING THE IVUS CATHETER, IT BECAME CAUGHT WITHIN THE STENT. THE IVUS CATHETER COULD BE ADVANCED, BUT NOT WITHDRAWN. THE PHYSICIAN ATTEMPTED TO REMOVE THE IVUS CATHETER SEVERAL TIMES, BUT WAS UNSUCCESSFUL. ANOTHER MANUFACTURER'S 3.0 X 15MM BALLOON WAS INSERTED AND THE IVUS CATHETER WAS ABLE TO BE RETRIEVED. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 3.0 X 16MM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR 3.0X15MM SPRINTER BALLOON| MACH 1 8F FCL4 GUIDE CATHETER