BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1243031 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04420
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025/521
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-04442. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, VESSEL DISSECTION AND STENT DISLODGEMENT OCCURRED. THE LESION WAS PRE-DILATED, UNK TYPE AND SIZE BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 ATOM DRUG ELUTING STENT, UNK SIZE, TO THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS, LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE STENT WAS NOT ON THE STENT DELIVERY CATHETER OR IN THE GUIDE CATHETER. THE STENT WAS FOUND IN THE PROXIMAL LAD AND ATTEMPTS TO SNARE THE STENT WERE UNSUCCESSFUL. THE PHYSICIAN WAS GOING TO BALLOON IT AGAINST THE VESSEL, BUT REALIZED A SPIRAL DISSECTION HAD OCCURRED. THE TAXUS WAS THEN STENTED AGAINST THE VESSEL WALL WITH ANOTHER STENT AND THE PATIENT WAS SENT TO SURGERY TO REPAIR THE DISSECTION. ADDITIONAL INFORMATION REGARDING THIS EVENT HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.25X8MM 11780041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention