BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1031788 · Received April 21, 2008

    Report

    Report Number
    2134265-2008-01142
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL RESISTANCE WAS ENCOUNTERED AND A DISSECTION OCCURRED. THE TARGET LESION, IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, WAS BEING TREATED FOR IN-STENT RESTENOSIS OF A NON-BSC STENT. A TAXUS EXPRESS2 2.5X24MM DRUG ELUTING STENT WAS POSITIONED AND DEPLOYED AT 8 ATMS AND WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON, THE GUIDE CATHETER WAS PULLED INTO THE OSTIUM OF THE LAD. A DISSECTION OF THE LAD OCCURRED. AS THE PHYSICIAN PULLED THE GUIDE CATHETER, THE GUIDE WIRE ALSO CAME BACK WHICH CAUSED THE PHYSICIAN TO LOSE THE WIRE PLACEMENT. WITH SOME DIFFICULTY, THE VESSEL WAS REWIRED WITH ANOTHER MANUFACTURER'S GUIDE WIRE AND A CHOICE PT GUIDE WIRE AND TWO MORE TAXUS STENTS WERE IMPLANTED TO TREAT THE DISSECTION. 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 2.5X24MM 11210310

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention REFLEX SOFT WIRE