BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1470978 · Received September 10, 2009

    Report

    Report Number
    2134265-2009-04628
    Event Type
    Injury
    Date Received
    September 10, 2009
    Date of Event
    February 1, 2006
    Report Date
    August 11, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS, AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. LITERATURE CITATION: YA-LING H, XIAO-ZENG W, QUAN-MIN J, SHOU-LI W ET AL. COMPARISON OF RAPAMYCIN AND PACLITAXEL ELUTING STENT IN PATIENTS WITH MULTI-VESSEL CORONARY DISEASE. FOREIGN JOURNAL OF CARIOLOGY 2006: 34: 123-130.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE JOURNAL ARTICLE TITLED: COMPARISON OF RAPAMYCIN AND PACLITAXEL ELUTING STENT IN PATIENTS WITH MULTI-VESSEL CORONARY DISEASE, THAT POST CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, AN UNSPECIFIED TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT WAS IMPLANTED. THE TARGET LESION LOCATION AND CHARACTERISTICS WERE NOT PROVIDED. AT SOME POINT POST-PROCEDURE, THE PATIENT UNDERWENT SECONDARY VESSEL RECONSTRUCTION/ REVASCULARIZATION OF THE TARGET LESION DUE TO IN-STENT RESTENOSIS. NO FURTHER INFORMATION IS AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention