BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040087 · Received May 7, 2008

    Report

    Report Number
    2134265-2008-01314
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTY AND STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MID TO PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS 90% STENOSED, >30 MM IN LENGTH, SEVERELY CALCIFIED, AND THE VESSEL WAS MODERATELY TORTUOUS. THE PHYSICIAN PREDILATED THE LESION WITH A 2.75 X 15 MM NON-BSC BALLOON, AND THEN CONFIRMED WITH INTRAVASCULAR ULTRASOUND. THE PHYSICIAN THEN ATTEMPTED TO DELIVER THE 3.00 X 32 MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE TAXUS STENT IN ORDER TO CHANGE THE GUIDE CATHETER, AND DURING WITHDRAWAL RESISTANCE WAS FELT. AFTER WITHDRAWAL, IT WAS NOTED THE STENT HAD DISLODGED AND WAS ON THE GUIDE WIRE. THE DISLODGED STENT WAS REMOVED SUCCESSFULLY WITH A SNARE AND IT WAS WITHDRAWN AS ONE UNIT WITH THE GUIDE CATHETER AND SHEATH. THE PHYSICIAN FELT THAT THE STENT WAS CAUGHT ON THE GUIDE CATHETER TIP, AND THE RESISTANCE WAS FELT WHEN IT WAS WITHDRAWN AND THE STENT DELIVERY SYSTEM SHAFT WAS STRETCHED. THE PHYSICIAN SUCCESSFULLY COMPLETED THE PROCEDURE WITH A 3.00 X 16 MM AND 3.00 X 20 MM TAXUS EXPRESS2 DRUG ELUTING STENT. NO PT COMPLICATIONS WERE REPORTED AND THE PT CONDITION IS LISTED 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 CORPORATION 3.00X32MM 9679732

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LACROSSE BALLOON| GUIDE CATHETER: LANCHERAL2| RUNTHROUGH NS HYPERCOAT| GUIDE WIRE: RUNTHROUGH