BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2111254 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02072
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: (B)(6) 2008. 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

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A SPIKE IN BLOOD PRESSURE AND PAIN. IN (B)(4) OF 2008, A 2.5X20MM TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE CIRCUMFLEX ARTERY (CX). IT WAS NOTED THAT THE PATIENT HAD NOT HAD ANY COMPLICATIONS UNTIL "RECENTLY". THE PATIENT IS EXPERIENCING SORE AND TENDER SKIN OVER THE AREA WHERE THE STENT WAS IMPLANTED AND SHE ALSO HAS PAIN IN HER RIBS. THE PATIENT HAS ALSO EXPERIENCED SPIKES IN HER BLOOD PRESSURE AND IT WAS NOTED THAT EVERY TIME THE PATIENT LIFTS SOMETHING, SHE FEELS A "LUMP BETWEEN HER BREAST BONE". IT WAS NOTED THAT THE PATIENT ALSO HAD A SMALL "EPISODE" AFTER THE IMPLANT PROCEDURE. THE PATIENT'S CURRENT CONDITION IS OKAY. ADDITIONAL INFORMATION WAS REQUESTED AND 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 H7493896820250 9564953

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other