BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 926245 · Received October 11, 2007

    Report

    Report Number
    6000089-2007-01370
    Event Type
    Injury
    Date Received
    October 11, 2007
    Date of Event
    September 12, 2007
    Report Date
    September 12, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    9030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    SAME CASE AS: 6000084-2007-00052. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING PROCEDURE, THE STENT DID NOT FULLY EXPAND. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, SEVERELY TORTUOUS PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE IMAGING CATHETER WAS UNABLE TO CROSS THE LESION, SO A ROTABLATOR WAS USED WITH A 1.5MM BURR FOR DEBULKING. THE PHYSICIAN DECIDED TO JUST TREAT THE PROXIMAL LAD. THE LESION WAS PREDILATED WITH A 2.5X14 MM NON-BSC BALLOON. A 2.75X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS IMPLANTED AT 16 ATM. THEN THE IVUS CATHETER WAS ADVANCED, PARTIALLY CROSSING THE STENTED SEGMENT. IVUS SHOWED THE STENT WAS NOT FULLY EXPANDED. UPON REMOVAL, THE IMAGING CATHETER GOT STUCK IN THE STENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE IT BY: PULLING THE GUIDEWIRE; REMOVING THE INNER SHAFT, THEN ADVANCING THE GUIDEWIRE THROUGH THE OUTER SHAFT AND PUSHING; ADVANCING THE BALLOON THROUGH THE OUTER SHAFT AND INFLATING; ADVANCING ANOTHER GUIDEWIRE ALONG THE OUTER SHAFT, THEN ADVANCING THE BALLOON AND INFLATING. ALL METHODS OF REMOVAL WERE UNSUCCESSFUL. AS A RESULT, THE PHYSICIAN CUT THE PROXIMAL END OF THE OUTER SHAFT, AND ADVANCED A TERUMO SHEATH ONTO THE OUTER SHAFT. THEN THE CATHETER WAS REMOVED FROM THE BODY. SURGERY WAS NOT REQUIRED. THE TAXUS STENT WAS POST DILATED AND REMAINS IN THE PATIENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS REPORTED 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 2.75X16 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 2.5X14 MM SPEEDER