BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 880103 · Received July 12, 2007

    Report

    Report Number
    6000089-2007-00968
    Event Type
    Injury
    Date Received
    July 12, 2007
    Date of Event
    October 26, 2006
    Report Date
    June 14, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    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

    CLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT HAD A STENT THROMBOSIS (ST) AND TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) FOR IN STENT RESTENOSIS. THE LESION WAS 4.0 MM WIDE, 8 MM LONG AND 99% STENOSED. THERE WAS MILD CALCIFICATION AND TORTUOUSITY. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 3.5 X 20 MM TAXUS EXPRESS2 STENT. POST DILATATION STENOSIS WAS 0%. THE PATIENT RECEIVED ASPIRIN DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 485, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THE PATIENT CONTACTED THE SITE COMPLAINING OF CHEST PAIN WAKING HIM FROM SLEEP. HIS NORMAL DOCTOR WAS OUT OF TOWN. THE PATIENT RESUME PLAVIX (HAD PREVIOUSLY STOPPED), NITRATES AND WAS ADMITTED FOR FURTHER EVALUATION. AN ANGIOGRAM CONFIRMED THE ST, AS WELL AS FOCAL IN-STENT RESTENOSIS (ISR). THE PATIENT HAD A TVR 4 DAYS LATER TO TREAT THIS ST AND ISR. THE TVR CONSISTED OF CORONARY ARTERY BYPASS GRAFTING (CABG) TO THE DISTAL RCA. THE PATIENT WAS DISCHARGED 4 DAYS LATER, WITH THE EVENTS RESOLVED. IN THE OPINION OF THE PHYSICIAN, THERE IS A PROBABLE RELATIONSHIP BETWEEN THE TAXUS STENT AND THE ST/TVR.

    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 CORPORATION 3.5 X 20 MM 7582062

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L| R