BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1192130 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02932
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    July 28, 2008
    Report Date
    September 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

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO THE "ANTICIPATED PROCEDURAL COMPLICATION". THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 199 DAYS FOLLOWING A CORONARY ARTERY STENTING PROCEDURE THAT THE PT RETURNED WITH IN-STENT RESTENOSIS REQUIRING REINTERVENTION. THE INDEX PROCEDURE TREATED THE 75% STENOSED AND MILDLY CALCIFIED 2.5X5MM LESION LOCATED IN THE MID LAD (LEFT ANTERIOR DESCENDING) ARTERY. TREATMENT CONSISTED OF PRE-DILATION WITH AN UNKNOWN 2.0X14MM BALLOON INFLATED TO 6 ATM'S AND THE PLACEMENT OF A 2.5X8MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE MID LAD, RESULTING IN 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED TWO DAYS POST THE PROCEDURE. THE PT RETURNED FOR A 6 MONTH STUDY REQUIRED FOLLOW UP VISIT AND SILENT ISCHEMIA DUE TO IN STENT RESTENOSIS WAS CONFIRMED VIA AN ANGIOGRAM. REINTERVENTION CONSISTENT OF BALLOON ANGIOPLASTY AND THE IMPLANT OF A COMPETITOR STENT OF AN UNKNOWN SIZE AGAIN RESULTING IN 0% RESIDUAL STENOSIS. THE PT WAS DISCHARGED TWO DAYS POST THE INTERVENTION PROCEDURE. PT HAS MEDICATION HISTORY OF ASPIRIN, PLAVIX AND HEPARIN. THE EVENT WAS LISTED BY THE INVESTIGATOR AS "POSSIBLY RELATED" TO THE TAXUS EXPRESS2 STENT.

    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 2.50X8MM 9763857

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R