BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1012348 · Received February 12, 2008

    Report

    Report Number
    2134265-2008-00749
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    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, STENT DAMAGE AND A STENT DISLODGEMENT OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE PROXIMAL PORTION OF THE RCA WAS SEVERELY CALCIFIED. THE LESION WAS PREDILATED WITH ANOTHER MFR'S 3.0X9MM BALLOON. PRE-IVUS WAS PERFORMED. THE PHYSICIAN ATTEMPTED TO ADVANCE A TAXUS EXPRESS2 3.0X16MM DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS "TO A REGION OF SHOULDER" OF THE PROXIMAL RCA DUE TO THE SEVERE CALCIFICATION. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT A PROXIMAL STENT STRUT WAS LIFTED. THE PHYSICIAN MANUALLY FIXED IT "WITH HIS HAND" AND ATTEMPTED TO ADVANCE THE DEVICE AGAIN, BUT WAS STILL UNABLE TO CROSS THE LESION. AS THE DEVICE WAS WITHDRAWN FROM THE PATIENT, THE STENT DISLODGED JUST SHORT OF THE GUIDE CATHETER. THE DISLODGED STENT WAS ABLE TO BE RETRIEVED WITH A SNARE. THE LESION WAS DILATED AGAIN AND THE PROCEDURE WAS ENDED. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT 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 16MM 9644622

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6FR. LAUNCHER GUIDE CATHETER| RUNTHROUGH GUIDE WIRE| 3.0X9MM SPRINTER BALLOON