BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1052103 · Received May 21, 2008

    Report

    Report Number
    2134265-2008-01466
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PHYSICIAN ATTEMPTED TO DIRECT STENT A TAXUS EXPRESS2 3.5X32MM DRUG ELUTING STENT TO THE 90% STENOSED LESION LOCATED IN THE CALCIFIED, SEVERELY TORTUOUS,, PROXIMAL RIGHT CORONARY ARTERY (RCA), BUT WAS UNABLE TO CROSS THE LESION. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT TO PRE-DILATE THE LESION WITH A NOTED THAT THE STENT EDGE WAS FLARED. THE PHYSICIAN THEN ATTEMPTED TO PRE-DILATED THE LESION WITH A NON BSC 3.5X15MM BALLOON, BUT THE BALLOON WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED BY DIRECT STENTING WITH A NON BSC STENT, UNKNOWN SIZE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS GOOD.

    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 3.5X32MM 9466442

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVER STENT| MEDTRONIC INFLATION DEVICE| RUNTHROUGH GUIDEWIRE| IKAZUCHI BALLOON| TERUMO SHEATH