BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL - ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242998 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04448
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    August 6, 2008
    Report Date
    October 24, 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 FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST 147 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE. THE INDEX PROCEDURE IDENTIFIED AND TREATED ONE TARGET LESION OF THE DE NOVO, MID RCA (RIGHT CORONARY ARTERY) MEASURING 3.0X20MM WITH 90% STENOSIS. THE LESION WAS PREDILATED USING 2.50X15MM BALLOON, A 2.5X16MM TAXUS EXPRESS2 STENT WAS PLACED, AND POST DILATED USING THE PREDILATION BALLOON. THE STENT WAS WELL EXPANDED WITH 0% RESIDUAL STENOSIS CONFIRMED BY INTRAVASCULAR ULTRASOUND. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS AND THE PATIENT WAS DISCHARGED THREE DAYS POST PROCEDURE. THE PATIENT EXPERIENCED CARDIAC ARREST 147 DAYS FOLLOWING THE INITIAL PROCEDURE AND WAS HOSPITALIZED WITH MILD CONGESTION, BILATERAL PLEURAL EFFUSION, AND MILD LEG EDEMA. ON DAY 154, THE PATIENT WAS DIAGNOSED WITH SILENT ISCHEMIA, POSSIBLY RELATED TO THE TAXUS EXPRESS2 STENT. THE PATIENT REMAINED HOSPITALIZED AND UNDERWENT A REINTERVENTION ON DAY 161. THE MID LAD (LEFT ANTERIOR DESCENDING) WAS FOUND TO HAVE 100% STENOSIS AND WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF AN UNKNOWN SIZE TAXUS EXPRESS2 STENT RESULTING IN 4% RESIDUAL STENOSIS. THE INTERVENTION OF THE MID LAD WAS UNRELATED TO THE STUDY DEVICE ACCORDING TO THE INVESTIGATOR. THE PATIENT HAD ANEMIA ORIGINALLY PRIOR TO THE REINTERVENTION (ASIDEROTIC ANEMIA AND RENAL ANEMIA). THE ANEMIA PROGRESSED DUE TO BLEEDING DURING THE REINTERVENTION AND A BLOOD TRANSFUSION WAS PERFORMED. SILENT ISCHEMIA WAS CONFIRMED TO CONTINUE ON DAY 174. ON DAY 175, ANOTHER REINTERVENTION WAS PERFORMED ON THE 90% STENOSED MID RCA USING AN UNKNOWN SIZE TAXUS EXPRESS2 STENT AND THE 90% STENOSED PROXIMAL RCA WAS TREATED WITH BALLOON ANGIOPLASTY AND ANOTHER MANUFACTURER'S DRUG ELUTING STENT. FOLLOWING REINTERVENTION, THE SILENT ISCHEMIA WAS IMPROVED. THE PATIENT WAS DISCHARGED ON DAY 195.

    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 2.5X16MM 11237281

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention