BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1761352 · Received July 19, 2010

    Report

    Report Number
    2134265-2010-03402
    Event Type
    Injury
    Date Received
    July 19, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.BSC ID: A00230166/TW# 1637914

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED IDIOPATHIC PULMONARY FIBROSIS. A TAXUS EXPRESS2 STENT ALONG WITH A NON BSC STENT HAD BEEN IMPLANTED IN AN UNSPECIFIED LESION AND TWO TO THREE MONTHS LATER THE PATIENT BEGAN HAVING RESPIRATORY SYMPTOMS AND WAS DIAGNOSED WITH IDIOPATHIC PULMONARY FIBROSIS. IT IS NOT BELIEVED THAT THE PATIENT'S SYMPTOMS ARE RELATED TO A HYPERSENSITIVITY REACTION TO THE IMPLANTED STENTS, AND IT WAS NOTED THAT THE PATIENT HAS NOT BEEN TREATED FOR THEIR SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Other XIENCE STENT