BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1841725 · Received September 22, 2010

    Report

    Report Number
    2134265-2010-04315
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    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# 2134265-2010-04316. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND UNDERWENT SURGERY. A 3.50X32MM TAXUS EXPRESS2 STENT ALONG WITH A 3.00X16MM TAXUS EXPRESS2 STENT WERE IMPLANTED IN AN UNSPECIFIED LESION IN (B)(6) 2004. IN (B)(6) 2006, THE PATIENT EXPERIENCED CHEST PAIN THAT LASTED 15 TO 20 SECONDS. THAT SAME YEAR THE PATIENT HAD "CHEST SURGERY". THE PATIENT'S CHEST PAIN HAS BECOME WORSE AND IS OCCURRING DAILY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS UNAVAILABLE.

    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 - GALWAY H7493897032350 6211143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 3.00X16MM TAXUS EXPRESS2 STENT