BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1111551 · Received August 13, 2008

    Report

    Report Number
    2134265-2008-02305
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE TAXUS EXPRESS2 DIRECTIONS FOR USE (DFU). THE CONDITION OF THE TARGET LESION WAS 95% STENOSED. THIS COULD HAVE BEEN A POTENTIAL CONTRIBUTING FACTOR TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2134265-2008-02306. IT WAS REPORTED THAT 653 DAYS AFTER A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH SILENT ISCHEMIA AND RESTENOSIS. THE PATIENT PRESENTED FOR TREATMENT WITH AN ACUTE MYOCARDIAL INFARCTION. THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS A 2.75MM, 95% STENOSED, 14MM LONG PORTION OF THE PROXIMAL LEFT ANTERIOR DESCENDING (PROX LAD) ARTERY. AFTER PREDILATATION THE VESSEL WAS OCCLUDED. THE PHYSICIAN PLACED A 2.75X16MM TAXUS STUDY STENT IN THE TARGET LESION. THE PHYSICIAN PLACED A 2.5X24MM TAXUS STUDY STENT, DISTAL TO THE FIRST TAXUS STENT, WITH A GAP BETWEEN BOTH STENTS. THE PATIENT WAS DISCHARGED 7 DAYS LATER. SIX HUNDRED AND FIFTY THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH SILENT ISCHEMIA. THE PATIENT WAS ASYMPTOMATIC. STRESS ECHO SHOWED RESTENOSIS TO THE PROXIMAL MARGINAL BORDER OF THE TAXUS STENT AND WAS TREATED WITH POBA. THE PATIENT WAS DISCHARGED THE SAME DAY. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE TAXUS STENTS IS POSSIBLY RELATED.

    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 2.75X16MM 8216308

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R