BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 1253119 · Received December 5, 2008

    Report

    Report Number
    2134265-2008-04592
    Event Type
    Injury
    Date Received
    December 5, 2008
    Report Date
    November 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    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

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED, AS THE BATCH NUMBER IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF TIME FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT DEVELOPED IN-STENT RESTENOSIS. AN UNKNOWN SIZE TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE RCA (RIGHT CORONARY ARTERY). AN UNSPECIFIED AMOUNT OF TIME LATER, IN-STENT RESTENOSIS WAS DISCOVERED. THE PROXIMAL RCA WAS 90% STENOSED AND MODERATELY TORTUOUS. TREATMENT CONSISTED OF BALLOON ANGIOPLASTY. THE PATIENT WAS REPORTED TO BE "FINE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention