BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1101744 · Received August 7, 2008

    Report

    Report Number
    2134265-2008-02228
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 5, 2006
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT 89 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE PATIENT DEVELOPED ACUTE CORONARY SYNDROME. THE PATIENT PRESENTED FOR TREATMENT WITH AN ACUTE MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED THE 75% RESTENOTIC, 3.0X8MM MID LAD (LEFT ANTERIOR DESCENDING) LESION USING A 3.0X16MM TAXUS EXPRESS2 DRUG ELUTING STENT. THE PATIENT PRESENTED 89 DAYS POST PROCEDURE WITH ANGINAL PAIN RADIATING INTO THE PATIENT'S BACK. THE PATIENT ALSO EXPERIENCED DIARRHEA AND LOWER LEG PAIN. MYOCARDIAL INFARCTION AND ACUTE CORONARY SYNDROME WERE DIAGNOSED. PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY AND STENT IMPLANTATION IN THE MID LCX (CIRCUMFLEX) DUE TO 80% STENOSIS. THE INVESTIGATOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE DEVICE. FURTHER EVALUATION OF THE PATIENT'S SYMPTOMS ALSO LED TO A DIAGNOSIS OF ALLERGIC COLITIS. DUE TO THE PATIENT'S REFUSAL OF FURTHER TESTING, THE PATIENT WAS DISCHARGED 13 DAYS FOLLOWING THE EVENT.

    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 3.0X16MM 7589502

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R