BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 889709 · Received August 3, 2007

    Report

    Report Number
    6000093-2007-01477
    Event Type
    Injury
    Date Received
    August 3, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 11, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS MDR# 2954755-2007-00035. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT AND FILTERWIRE REMOVAL DIFFICULTIES OCCURRED. THE LESION BEING TREATED WAS LOCATED IN A VEIN GRAFT TO THE CIRCUMFLEX (CX). A FILTERWIRE EZ DEVICE WAS IN PLACE IN THE VEIN GRAFT TO THE CX. A 3.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS ADVANCED OVER THE FILTERWIRE, HOWEVER, THERE WAS A PREVIOUS STENT OF UNKNOWN SIZE AND TYPE IN THE VEIN GRAFT THAT WAS POSING A CHALLENGE AS FAR AS GETTING THE TAXUS STENT TO THE LESION IN THE VEIN GRAFT. THE TAXUS STENT KEPT GETTING "HUNG UP ON THE PREVIOUSLY PLACED STENT." THE PHYSICIAN TRIED TO REMOVE THE STENT FROM THE VEIN GRAFT, BUT IN DOING SO THE 3.50X16MM TAXUS STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN THEN TRIED TO REMOVE EVERYTHING AS A UNIT (THE GUIDE CATHETER, THE STENT THAT CAME OFF, AND THE DEPLOYED FILTERWIRE) BUT THE PHYSICIAN HAD JUST DEPLOYED AS ILIAC STENT OF UNKNOWN SIZE AND TYPE AND THE DEPLOYED FILTERWIRE GOT HUNG UP ON THE ILIAC STENT. THE PHYSICIAN TRIED TO CAPTURE THE TAXUS STENT WITH THE GUIDE CATHETER AND IN DOING SO THE PHYSICIAN LOST THE STENT, AND WAS UNABLE TO FIND AND RETRIEVE THE STENT. THE PATIENT CONDITION IS LISTED AS FINE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    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 3.50X16MM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention