BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231242 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03632
    Event Type
    Injury
    Date Received
    September 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE - ON OR ABOUT (B)(6) 2007. 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

    SAME CASE AS MFR#: 2134265-2011-03633 AND 2134265-2011-03623. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. IN (B)(6), 2006, THE PATIENT WAS ADMITTED TO THE TREATING FACILITY COMPLAINING OF CHEST PAIN AND ACUTE MYOCARDIAL INFARCTION. THE LESIONS BEING TREATED WERE LOCATED IN THE 70% STENOSED LEFT ANTERIOR DESCENDING (LAD) ARTERY, 80% STENOSED DIAGONAL (DX) ARTERY, AND 80% STENOSED MID RIGHT CORONARY ARTERY (RCA). THE LESIONS WERE SUCCESSFULLY TREATED WITH A 2.5X8MM TAXUS EXPRESS2 STENT (PROXIMAL), A 2.5X16MM TAXUS EXPRESS2 STENT, A 3.5X16MM TAXUS EXPRESS2 (MID LAD), AND A 3.5X20 TAXUS EXPRESS2 (MID RCA). ON OR ABOUT (B)(6) 2007, THE PATIENT PRESENTED WITH CHEST PAIN AND NAUSEA. THROMBOSIS WAS IDENTIFIED IN THE OVERLAPPING LAD AND DX STENTS. IT IS UNKNOWN HOW THE THROMBOSIS WAS TREATED.

    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 Other