BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2243664 · Received September 12, 2011

    Report

    Report Number
    2134265-2011-03847
    Event Type
    Death
    Date Received
    September 12, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS 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# 2134265-2011-03844, 2134265-2011-03845, 2134265-2011-03846 AND 2134265-2011-03849 IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. FIVE TAXUS EXPRESS2 STENTS WERE IMPLANTED; IT WAS NOTED THAT THREE OF THE STENTS WERE IMPLANTED IN 2004, AND IT IS UNKNOWN WHEN THE OTHER TWO STENTS WERE IMPLANTED. IN (B)(6) 2011, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND THE PATIENT LATER EXPIRED. 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 UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (4) TAXUS EXPRESS2 STENTS