BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1000409 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00487
    Event Type
    Injury
    Date Received
    February 20, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HAIR LOSS OCCURRED. THE PHYSICIAN IMPLANTED A 3.00X32MM TAXUS EXPRESS2 DRUG ELUTING STENT, AND A 3.00X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN AN UNSPECIFIED LOCATION. TWO TO THREE WEEKS LATER, THE PATIENT NOTICED HAIR LOSS. ADDITIONALLY, THE PT REPORTS DIFFICULTY BREATHING. THE PHYSICIAN DOES NOT KNOW IF THE HAIR LOSS IS RELATED TO THE TAXUS STENTS. FURTHER INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE.

    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 CORPORATION 3.00X32MM 9740817

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other