BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1003985 · Received February 25, 2008

    Report

    Report Number
    2134265-2008-00533
    Event Type
    Injury
    Date Received
    February 25, 2008
    Report Date
    January 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. 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 BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASES AS MFR # 2134265-2008-00534, 2134265-2008-00535, 2134265-2008-00536. IT WAS REPORTED BY THE PT'S SPOUSE THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, ALLERGIC REACTION OCCURRED. THE PT PRESENTED WITH AN ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION AND HAD A TOTALLY OCCLUDED LEFT ANTERIOR DESCENDING (LAD). THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 STENT OF UNK SIZE. AFTER THE PROCEDURE, THE PT DEVELOPED A CIRCULAR RASH ON HER MID SECTION. FIFTY DAYS LATER, THE PT PRESENTED FOR A PREVIOUSLY SCHEDULED PROCEDURE, IN WHICH THE LEFT CIRCUMFLEX AND RIGHT CORONARY ARTERIES WERE STENTED WITH THREE TAXUS EXPRESS2 STENTS, SIZES 3.50X12MM, 3.00X32MM, AND 3.00X32MM (IT IS UNCLEAR WHICH STENT WAS PLACED IN WHICH ARTERY). A FEW DAYS AFTER RECEIVING THE THREE STENTS, THE PT DEVELOPED A RASH ALL OVER, INCLUDING ON HER BACK, BUTTOCKS CHIN, THROAT, UNDERARMS AND ARMS. THE PT'S PHYSICIAN HAS DISCONTINUED ALL OF HER MEDICATIONS, EXCEPT HER PLAVIX, AND SHE HAS BEEN TAKING BENADRYL DAILY. FOLLOW UP WITH THE PT'S PHYSICIAN WAS PERFORMED, HOWEVER, THE PHYSICIAN WAS UNABLE TO SUPPLY ANY INFO AS TO WHAT THIS ALLERGIC REACTION CONSISTED OF AND WHAT MAY HAVE BEEN THE OFFENDING AGENT.

    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 3.50X12MM 9486995

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention