BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1912925 · Received December 2, 2010

    Report

    Report Number
    2134265-2010-05256
    Event Type
    Injury
    Date Received
    December 2, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2010-05170 AND 2134265-2010-05171. IT WAS REPORTED BY THE PATIENT THAT POST A STENTING TREATMENT PROCEDURE, HAIR LOSS OCCURRED. THE PATIENT HAD THREE TAXUS EXPRESS2 STENTS IMPLANTED, SIZE 3.5X12MM, 3.0X12MM AND 3.5X16MM. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED HAIR LOSS WHICH CONTINUES AT THE CROWN. THE TEXTURE OF THE PATIENT'S HAIR IS "DRY AND FRIZZY." THE PATIENT REPORTED NORMAL THYROID STUDIES SINCE THE STENT IMPLANTATION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493897012350 8979523

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 3.0X12 TAXUS EXPRESS2 STENT| 3.5X16 TAXUS EXPRESS2 STENT