BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST

    MDR report key: 769317 · Received October 11, 2006

    Report

    Report Number
    6000093-2006-02058
    Event Type
    Injury
    Date Received
    October 11, 2006
    Report Date
    September 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT, THEREFORE, NO ANALYSIS COULD BE PERFORMED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH #7241808 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S DAUGHTER THAT "SHORTLY" AFTER THE STENT WAS PLACED, THE PT EXPERIENCED ITCHING. A 2.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. "SHORTLY" AFTER THE STENT PLACEMENT THE PT "EXPERIENCED ITCHING, MOSTLY IN THE AREA OF THE HEAD (NO HIVES). SHE ALSO COULDN'T TALK OR THINK FOR A COUPLE OF DAYS", WHICH WAS FURTHER DESCRIBED AS "CONFUSION OR A SINKING FEELING." ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PHYSICIAN'S OFFICE, BUT HAS NOT BEEN REC'D AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY ST DRUG COAT STENT NIQ BOSTON SCIENTIFIC CORP. 2.5X16MM 7241808

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other