BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1163572 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02685
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A MAVERICK 2.5 X 15 MM BALLOON. THE PHYSICIAN THEN PLACED A TAXUS EXPRESS2 3.5 X 20 MM DRUG ELUTING STENT TO THE MIDLY CALCIFIED AND MIDLY TORTUOUS BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN THEN ATTEMPTED TO WIRE BACK THROUGH THE STENT IN THE LAD TO A DIAGONAL (DX) LESION, BUT A THROMBOSIS OCCURRED. THE PT WAS THEN PLACED ON AN INTRA-AORTIC BALLOON PUMP (IABP) AND TAKEN TO SURGERY. CORONARY ARTERY BYPASS GRAFTING (CABG) WAS COMPLETED AND THE PT'S STATUS POST SURGERY IS NOTED AS FINE.

    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 3.5X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention