BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1111870 · Received August 12, 2008

    Report

    Report Number
    2134265-2008-02277
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. THE BATCH NUMBER OF THIS COMPLAINT IS UNKNOWN, THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE BOSTON SCIENTIFIC CORPORATION DESIGN AND MANUFACTURING SPECIFICATION, BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGMENT OCCURRED. THE PHYSICIAN IMPLANTED TWO TAXUS EXPRESS2 DRUG ELUTING STENTS, UNKNOWN SIZE, TO THE 90% STENOSED LESION LOCATED IN THE CALCIFIED AND EXTREMELY TORTUOUS MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN THEN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.0X28MM DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE PREVIOUSLY PLACED STENTS. THE 3.0X28MM TAXUS STENT DISLODGED INSIDE THE PREVIOUSLY IMPLANTED STENTS. A QUANTUM MAVERICK 3.0X20MM BALLOON AND A MAVERICK 3.0X20MM BALLOON WERE THEN USED TO DILATE THE DISLODGED STENT AND PERFORM KISSING BALLOON TECHNIQUE. NO FURTHER 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 3.0X28MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention