BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1032340 · Received April 22, 2008

    Report

    Report Number
    2134265-2008-01159
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 99 % STENOSED LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS POSTERIOR DESCENDING ARTERY (PDA). THE DIAMETER OF THE VESSEL WAS 3.5MM. THE LESION WAS PREDILATED WITH A 2.5X 15MM NON-BSC BALLOON. THE PHYSICIAN ATTEMPTED TO ADVANCE A TAXUS EXPRESS2 3.0 X 24MM DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. THE LESION WAS AGAIN PREDILATED WITH A 3.5 X 15MM NON-BSC BALLOON AND THE PHYSICIAN ATTEMPTED TO ADVANCE THE TAXUS EXPRESS2 STENT DELIVERY SYSTEM (SDS), BUT WAS STILL UNABLE TO CROSS THE LESION. AS THE DEVICE WAS WITHDRAWN FROM THE PT, THE SDS CAUGHT ON THE GUIDE CATHETER AND THE DEVICE WAS UNABLE TO BE REMOVED. THE PHYSICIAN THEN PULLED THE SDS AND GUIDE CATHETER OUT TOGETHER; HOWEVER, THE STENT WAS NOT ON THE BALLOON WHEN THE DEVICE WAS REMOVED. THE DISLODGED STENT WAS REMOVED WITH A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MFR'S 2.5 X 13MM STENT. NO FURTHER PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    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 3.0 X 24MM 11059855

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention 2.5X13MM CYPHER STENT| 2.5X15MM ROSSO BALLOON| 3.5X15MM ROSSO BALLOON