BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1095513 · Received July 30, 2008

    Report

    Report Number
    2134265-2008-02192
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    March 18, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    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 EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, A DISSECTION OCCURRED. THE INDEX PROCEDURE TREATED A 90% STENOSED, 3.0X70MM PROXIMAL RCA (RIGHT CORONARY ARTERY) LESION AND A 90% STENOSED, 2.5X25MM R-PAV (RIGHT POSTERIOR ATRIOVENTRICULAR) LESION. THE PROXIMAL RCA LESION WAS PREDILATED WITH A 3.0X18MM BALLOON AND THREE TAXUS EXPRESS2 DRUG ELUTING STENTS WERE PLACED (3.0X32MM, 3.5X24MM, AND 3.5X20MM) AND POST DILATED. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE PLACEMENT OF THE PROXIMAL PCA STENTS. THE R-PAV LESION WAS PREDILATED WITH A 2.5X20MM BALLOON AND A 2.75X28MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS PLACED. A DISSECTION OCCURRED AND ANOTHER MFR'S BARE METAL STENT WAS USED TO TREAT THE DISSECTION. THE PT WAS DISCHARGED TWO DAYS POST PROCEDURE ON ASA AND PLAVIX. THE PHYSICIAN REPORTED THE EVENT WAS POSSIBLY RELATED TO THE DEVICE.

    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 2.75X28MM 11103457

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention