BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1032364 · Received April 22, 2008

    Report

    Report Number
    2134265-2008-01150
    Event Type
    Injury
    Date Received
    April 22, 2008
    Report Date
    March 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 INFO FROM THAT 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, STENT DISLODGEMENT OCCURRED. THE LESION WAS PRE-DILATED MULTIPLE TIMES WITH MULTIPLE BALLOONS, UNK TYPES AND SIZES. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.0X12MM DRUG ELUTING STENT TO THE SEVERELY TORTUOUS, SEVERELY CALCIFIED, PROXIMAL CIRCUMFLEX (CX) ARTERY, BUT WAS UNABLE TO CROSS THROUGH TWO PREVIOUSLY PLACED TAXUS STENTS. RESISTANCE WAS MET UPON WITHDRAWAL AND THE STENT DISLODGED INSIDE A PREVIOUSLY PLACED STENT IN THE PROXIMAL CX. THE PHYSICIAN THEN USED A BALLOON, UNK TYPE, TO CRUSH THE DISLODGED STENT AGAINST THE WALL OF THE PREVIOUSLY PLACED STENT. A LIBERTE' 3.0 X 8MM BARE METAL STENT WAS DEPLOYED IN THAT SAME AREA. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE 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 CORPORATION 3.0 X12MM 11154996

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention