BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1781540 · Received August 3, 2010

    Report

    Report Number
    2134265-2010-03280
    Event Type
    Injury
    Date Received
    August 3, 2010
    Report Date
    July 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2008. DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. AS A UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS CANNOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-03279 AND 2134265-2010-03281. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, LATE STENT THROMBOSIS OCCURRED. IN (B)(6) OF 2008, THREE TAXUS EXPRESS2 STENTS WERE PLACED IN AN UNSPECIFIED CORONARY ARTERY; A 2.75X32MM, A 3.0X24MM AND ONE OF UNKNOWN SIZE. NO PATIENT COMPLICATIONS WERE REPORTED. FIVE MONTHS LATER THE PATIENT PRESENTED WITH ANGINA. THE STENTS WERE OCCLUDED WITH THROMBUS. TWO STENTS WERE PLACED TO TREAT THE THROMBOSIS. NO FURTHER COMPLICATIONS WERE REPORTED. NINE MONTHS LATER THE PATIENT AGAIN PRESENTED WITH ANGINA. IT WAS NOTED THAT THE STENTS WERE AGAIN OCCLUDED WITH THROMBUS. THE PATIENT UNDERWENT BYPASS SURGERY AT THAT TIME. NO FURTHER PATIENT COMPLICATIONS OCCURRED. THE PATIENT IS CURRENTLY TAKING PLAVIX AND ASPIRIN AND REPORTS NO CARDIAC SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897024300 0011212895

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN SIZE TAXUS EXPRESS2 STENT| 2.75X32MM TAXUS EXPRESS2 STENT