BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1003534 · Received February 26, 2008

    Report

    Report Number
    6000089-2008-00018
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERLY TORTUOUS LEFT CIRCUMFLEX (LCX) OBTUSE MARGINAL (OM) AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED AND A 2.5X24 TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS IMPLANTED AT THE MID LAD AND A 3.5X23 NON BSC DEVICE WAS IMPLANTED IN THE PROXIMAL LAD. THE LESION AT THE LCX OM WAS DILATED WITH TWO NON BSC DEVICES, AND THEN THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A 2.5X16MM TAXUS EXPRESS2 DES, BUT THE VESSEL CURVE AT THE LCX OM WAS A RIGHT ANGLE AND CALCIFIED, AND THE DES WAS UNABLE TO CROSS THE LESION. THE DES WAS WITHDRAWN AND IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. IT WAS CONFIRMED WITH ANGIOGRAPHY THAT THE STENT WAS INSIDE THE PATIENT AT THE OSTIAL OF THE LCX OM. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE STENT WITH A SNARE, BUT WAS UNABLE TO WITHDRAW THE STENT FROM THE PATIENT. THE STENT WAS CRUSHED WITH A 3.0X15MM QUANTUM MAVERICK AND THE PROCEDURE WAS FINISHED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    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 2.50X24MM 9664554

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention