BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 793393 · Received December 8, 2006

    Report

    Report Number
    6000093-2006-02551
    Event Type
    Injury
    Date Received
    December 8, 2006
    Date of Event
    September 10, 2006
    Report Date
    November 10, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8132603 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THE CAUSE OF THE DIFFICULTIES STATED IN THE COMPLAINT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT EXPERIENCED CHEST PAIN. THE INDEX PROCEDURE TREATED A BIFURCATED LESION CONSISTING OF THE LEFT MAIN, PROXIMAL LAD AND CIRCUMFLEX ARTERIES. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 5.0X32MM TAXUS EXPRESS2 STENT, USING THE T-STENTING TECHNIQUE. POST DILATATION STENOSIS IS LESS THAN OR EQUAL TO 30%. THE PT RECEIVED BIVALIRUDIN DURING THE PROCEDURE. THE PT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 130, THE PT EXPERIENCED CHEST PAIN. THE PT WAS TAKEN FOR AN ANGIOGRAM, BUT NO OTHER INTERVENTION WAS PERFORMED. AT THAT TIME, THE PT WAS SCHEDULED FOR A PERCUTANEOUS CORONARY INTERVENTION AT ANOTHER HOSP.

    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 CORP. 5.0X32MM 8132603

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R