BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 801069 · Received January 3, 2007

    Report

    Report Number
    6000089-2007-00011
    Event Type
    Injury
    Date Received
    January 3, 2007
    Date of Event
    December 6, 2006
    Report Date
    December 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW THEREFORE A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. BOSTON SCIENTIFIC MANUFACTURING PROCESSES INCLUDE EXTENSIVE TESTING AND INSPECTIONS TO ENSURE EACH PRODUCT MEETS OR EXCEEDS ALL MATERIAL ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 8955215 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. THIS PARTICULAR BATCH NUMBER 8955215 HAS NO ASSOCIATED COMPLAINTS TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, SUB ACUTE THROMBOSIS (SAT) OCCURRED. THE PHYSICIAN PLACED A 2.50X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) TO TREAT A 100% STENOSIS. TWO DAYS LATER, THE PATIENT PRESENTED WITH AN EMERGENT MYOCARDIAL INFARCTION. "SAT WAS PRESENT FROM PROXIMAL PORTION OF STENT AND OCCLUDED LAD." THE PHYSICIAN USED IVUS AND "DETERMINED THE STENT WAS UNDERDEPLOYED. ACTUAL VESSEL SIZE WAS 3.5MM. STENT WAS 2.5MM AND DELIVERED WITH DELIVERY BALLOON ONLY." THE STENT WAS NOT POST DILATED. THE PHYSICIAN PERFORMED ANGIOPLASTY WITH A 3.5MM BALLOON OPENED THE VESSEL. PATIENT IS REPORTED AS FINE. THE PATIENT WAS TAKING BOTH PLAVIX AND ASPIRIN.

    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 2.50X16MM 8955215

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention