BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 767309 · Received October 5, 2006

    Report

    Report Number
    6000089-2006-02197
    Event Type
    Injury
    Date Received
    October 5, 2006
    Date of Event
    September 7, 2006
    Report Date
    September 7, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    na
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW; THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8893660 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE VESSEL RUPTURED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS PREDILATED USING A 2.5X20MM MAVERICK II BALLOON INFLATED TO 16 ATM FOR 10 SECONDS. THEN A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED AT 16 ATM. DURING THE PROCEDURE, THE VESSEL RUPTURED AND THE PATIENT WAS SENT TO THE OPERATING ROOM FOR CORONARY ARTERY BYPASS SURGERY. IT WAS REPORTED THE PHYSICIAN FELT THE VESSEL RUPTURE WAS NOT CAUSED BY THE STENT OR THE BALLOON, BUT WAS BECAUSE "THE PATIENT'S VESSEL WAS EASY TO FRACTURE". THE PATIENT CONDITION WAS REPORTED AS "UNSTABLE UNTIL NOW".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.5X24MM 8893660

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention