BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 919481 · Received September 26, 2007

    Report

    Report Number
    6000089-2007-01339
    Event Type
    Injury
    Date Received
    September 26, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    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: 6000089-2007-01338, 6000039-2007-01784, 6000093-2007-01784, 6000093-2007-01785. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING PROCEDURE, A DISSECTION OCCURRED AND POST THE PROCEDURE THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. PATIENT WAS TAKING BAYASPIRIN AND TICLOPIDINE. A 3.50X16MM TAXUS EXPRESS DRUG ELUTING STENT WAS PLACED IN THE 90% STENOSED LESION, LOCATED IN THE MILDLY CALCIFIED, NON-TORTUOUS RIGHT CORONARY ARTERY (RCA), INFLATED TO 18ATM FOR 10 SECONDS. THE 70-90% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED, MODERATELY TORTUOUS MILD, PROXIMAL AND DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE LESIONS WERE PREDILATED TO 14ATM (SIZE AND MANUFACTURER UNKNOWN). THE LCX A 3.0X28MM TAXUS EXPRESS DRUG ELUTING STENT WAS PLACED IN THE DISTAL PORTION, INFLATED TO 16 ATM FOR 5 SECONDS. A 3.50X28MM TAXUS EXPRESS DRUG ELUTING STENT WAS PLACED IN THE MID PORTION, INFLATED TO 18ATM FOR 15 SECONDS. A 3.50X24MM TAXUS EXPRESS DRUG ELUTING STENT WAS PLACED IN THE PROXIMAL PORTION, INFLATED TO 20ATM FOR 10 SECONDS. THERE WAS OVERLAPPING OF THE STENTS. THESE STENTS WERE POST DILATED WITH A 3.X14MM NON BSC BALLOON (DISTAL), 3.50X28 MM TAXUS BALLOON (MID), AND A 4.0X14 MM NON-BCS BALLOON (PROXIMAL). IT IS NOTED THAT THE 3.50X24MM TAXUS STENT WAS PLACED DUE TO A DISSECTION NOTED AT THE PROXIMAL SIDE OF THE 3.50X28 MM TAXUS STENT. IVUS CONFIRMED THE STENTS WERE WELL APPOSED. PLAVIX WAS NOT PRESCRIBED FOURTEEN DAYS POST THE INITIAL PROCEDURE THE PATIENT PRESENTED WITH CHEST PAIN. THE PATIENT WAS TAKEN TO THE CATH LAB WHERE THROMBOSIS WAS IDENTIFIED IN ALL FOUR OF THE PREVIOUSLY PLACED STENTS. THE PROXIMAL RCA WAS 25-50% STENOSED AND THE LCS WAS 100% STENOSED. THE LCX WAS ASPIRATED WITH THROMBUSTER AND DILATED WITH A 3.25X13MM NON-BSC BALLOON. A BALLOON PUMP WAS PLACED AND THE PROXIMAL RCA WAS DILATED (BALLOON SIZE AND MANUFACTURER UNKNOWN). PATIENT WAS TAKING TICLOPIDINE, ASPIRIN, AND HEPARIN AT THE TIME OF THE EVENT.

    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 3.00X28MM 9493594

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 3.25X13 MM OTTIMO BALLOON| 4.0X14 MM AVION BALLOON| 3.0X14 MM SPEEDER BALLOON