BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1101703 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02242
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 PROD 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, A STENT EMBOLIZATION OCCURRED. THE 95% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, SEVERELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED WITH A 2.5X12MM MAVERICK, INFLATED TO 10 ATM. THE PHYSICIAN ATTEMPTED TO PLACE A 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. WHEN REMOVING THE ENTIRE DELIVERY DEVICE, THE TAXUS STENT BECAME SNAGGED ON THE CALCIFIED AND TORTUOUS VESSEL. THE TAXUS STENT DISLODGED FROM THE STENT DELIVERY BALLOON CLOSE TO THE LAD LESION. ATTEMPTS TO SNARE THE STENT WERE UNSUCCESSFUL. THE PHYSICIAN SUCCESSFULLY USED A 2.50X8MM TAXUS STENT TO PIN OR CRUSH THE UNDEPLOYED STENT AGAINST THE WALL OF THE ARTERY. THREE OR FOUR MILLIMETERS OF THE DISTAL PORTION OF THE TAXUS STENT WERE NOT COVERED BY THE 2.5X8 STENT, SO THE PHYSICIAN ATTEMPTED TO COVER THE REMAINING AREA WITH A 2.25X8MM NON-BSC STENT. THE PHYSICIAN WAS NOT SUCCESSFUL IN PLACING THE 2.25X8MM NON-BSC STENT. A STENT WAS NOT PLACED AT THE DESIRED TARGET VESSEL AND THE PROCEDURE WAS ENDED. PT STATUS REPORTED AS "STABLE".

    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 2.50X12 MM 11555254

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention MINI VISION STENT