BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143156 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02452
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 31, 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

    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, A STENT OCCLUSION OCCURRED. IN (B)(6) 2005, THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN IMPLANTED A 2.75X20MM TAXUS EXPRESS 2 STENT. IN MARCH 2011, THE PATIENT EXPERIENCED A HEART ATTACK. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY. THE PREVIOUSLY PLACED TAXUS EXPRESS 2 STENT WAS FOUND TO CONTAIN A CHRONIC TOTAL OCCLUSION. THE ATTEMPTS MADE TO PLACE NON-BSC GUIDE WIRES IN THE LAD WERE UNSUCCESSFUL. THE PHYSICIAN IMPLANTED A 3.0X28MM PROMUS STENT IN THE 99% STENOSED MID RIGHT CORONARY ARTERY (RCA) AND A 3.0X12MM PROMUS STENT WAS IMPLANTED IN THE 80% STENOSED MID POSTEROLATERAL ARTERY (PLA) WITH EXCELLENT RESULTS. RESIDUAL STENOSIS WAS 0% WITH A TIMI 3 FLOW. MEDICATIONS GIVEN INCLUDED: INTEGRILIN, PLAVIX, AND ASPIRIN. THE PATIENT WILL CONTINUE "AGGRESSIVE MEDICATION". HOWEVER, THE MEDICATION IS HURTING THE PATIENT'S ARMS, BRUISES IN THE BLOOD VESSELS UNDERNEATH THE BRACHIAL, AND ITCHING.

    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 H7493897020270 7138200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention