BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1461359 · Received September 1, 2009

    Report

    Report Number
    2134265-2009-04389
    Event Type
    Injury
    Date Received
    September 1, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 4, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC FOR ANALYSIS. AN ANALYSIS OF THE COMPLAINT DEVICE MAY HAVE AIDED IN ROOT CAUSE DETERMINATION. A REVIEW OF THE MANUFACTURING RECORDS RELATED TO THE BATCH THAT PRODUCED THE COMPLAINT DEVICE WAS NOT POSSIBLE BECAUSE THE BATCH NUMBER IS UNK. A PRODUCT SHIPMENT HISTORY REVIEW FOR THE REPORTED UPN WAS PERFORMED FOR THIS CUSTOMER. THE LAST BATCH THAT WAS SHIPPED TO THE CUSTOMER BEFORE THIS EVENT PROCEDURE DATE WERE 6872510. THE MFG RECORDS FOR THIS BATCH WAS REVIEWED, AND NO ANOMALIES WERE NOTED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2009-04391, 2134265-2009-04392, 2134265-2009-04393. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, VERY LATE STENT THROMBOSIS OCCURRED. THE PT HAD 4 TAXUS EXPRESS2 DRUG ELUTING STENTS PLACED IN THE RIGHT CORONARY ARTERY IN 2004. FOUR AND A HALF YEARS LATER THE PT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. THROMBUS WAS FOUND IN THE MOST DISTAL OF THE 4 PLACED STENTS WHICH WAS A 2.75X20MM TAXUS EXPRESS2 STENT. THE PHYSICIAN TREATED THE THROMBUS WITH A 3.0X20MM NON BSC BALLOON. NO FURTHER PT INJURIES OR COMPLICATIONS OCCURRED. THE PT WAS STABLE AND PLACED ON AN INTRA AORTIC BALLOON PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.75X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention (3) TAXUS EXPRESS2 STENTS