BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1024352 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00961
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    January 9, 2008
    Report Date
    March 10, 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, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO ANOMALIES OR DEVIATIONS DURING THE MFR OF THIS BATCH. THE MOST PROBABLE ROOT CAUSE OF THIS DEFECT WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO THE LIKELIHOOD THAT THE PT ANATOMY OR OTHER PROCEDURAL FACTORS CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. SAME CASE AS MFR REPORT #: 2134265-2008-00959. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PT EXPERIENCED SIDE BRANCH CLOSURE. THE TARGET LESION WAS A DE NOVO, 90% STENOSED LESION IN THE MID RCA (RIGHT CORONARY ARTERY) MEASURING 3.50X44MM. TWO TAXUS EXPRESS2 DRUG ELUTING STENTS (3.5X32MM AND 3.5X12MM) WERE DEPLOYED AT 20 ATMS. NO PRE-DILATION OR POST DILATATION WAS DONE. THERE WAS NO GAP BETWEEN THE STENTS. THE STENT IMPLANTATION RESULTED IN 0% RESIDUAL STENOSIS AND IVUS (INTRAVASCULAR ULTRASOUND) REVEALED THE STENTS WERE WELL APPOSED. HOWEVER, SIDE BRANCH CLOSURE WAS FOUND IN A SIDE BRANCH OF THE TARGET VESSEL. NO TREATMENT WAS NEEDED AS THIS WAS REPORTEDLY A MILD CASE. THE PT CONDITION WAS NOTED AS GOOD. THE PHYSICIAN ASSESSED THE EVENT AS POSSIBLY A PROCEDURAL FACTOR OR POSSIBLY RELATED TO THE TAXUS EXPRESS2 DRUG ELUTING STENTS.

    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 3.5X12MM 9732780

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention