BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1190311 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02924
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-02923. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTY OCCURRED AND BYPASS SURGERY WAS PERFORMED. THE LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED, VERY TORTUOUS MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN DEPLOYED A 3.00X12MM TAXUS STENT IN THE MID LAD. THEN THE PHYSICIAN WENT IN WITH A BUDDY WIRE AND USED A 2.5X15MM MAVERICK BALLOON TO DILATE THE LESION. THE PHYSICIAN ATTEMPTED TO PLACE A 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT IT BECAME STUCK ON THE PREVIOUSLY DEPLOYED 3.00X12MM TAXUS STENT. THE PHYSICIAN CONTINUED TO RETRACT THE STENT AND WAS SUCCESSFUL IN REMOVING THE 2.50X16MM STENT. ADDITIONAL ANGIO SHOTS WERE DONE AND THE 3.00X12MM STENT COULD NOT BE SEEN. THE 3.00X12MM STENT WAS LOCATED ON THE TABLE WITH THE 2.50X16MM TAXUS STENT. THE PT WAS TAKEN TO NON-EMERGENT BYPASS SURGERY.

    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 2.50X16 MM 11531103

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention