BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1083446 · Received July 29, 2008

    Report

    Report Number
    2134265-2008-02118
    Event Type
    Injury
    Date Received
    July 29, 2008
    Report Date
    July 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS WAS UNABLE TO BE PERFORMED. AS THE BATCH NUMBER IS UNK, A REVIEW OF THE MFG RECORDS CANNOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE IS CLASSIFIED AS ANTICIPATED PROCEDURAL COMPLICATION AS THE DEVICE RELATED ROOT CAUSE DOES NOT APPLY, AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 DRUG ELUTING STENT, UNK SIZE, TO THE POSTERIOR DESCENDING RIGHT CORONARY ARTERY (RCA). THE STENT WAS WELL POSITIONED AND WELL APPOSED. ASPIRIN AND PANALDINE WERE PRESCRIBED POST PROCEDURE. THE PT RETURNED WITH 90% IN-STENT RESTENOSIS IN THE POSTERIOR DESCENDING RCA. THE RESTENOSIS WAS TREATED WITH BALLOON DILATATION, UNK TYPE AND SIZE BALLOON. THE TIME FROM IMPLANTATION TO RESTENOSIS IS UNK. ADD'L INFO REGARDING THIS EVENT IS NOT AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention