BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1192122 · Received October 7, 2008

    Report

    Report Number
    2134265-2008-02948
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    November 14, 2005
    Report Date
    September 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    ATTORNEY

    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 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, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2008-02614. IT WAS REPORTED, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, CHEST PAIN AND HOSPITALIZATION OCCURRED. THE 70-80% STENOSED LESION BEING TREATED WAS LOCATED IN THE TORTUOUS, LIGHTLY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED WITH A 3.0X12MM MAVERICK BALLOON. THE PHYSICIAN DEPLOYED A 3.5X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, INFLATED TO 14 ATM, WITH NICE ANGIOGRAPHIC RESULTS. FOLLOW-UP ANGIOGRAPHY FOUND A SLIGHT ECCENTRICITY TO THE STENT WITH AN INDENTATION ALONG THE LESSER CURVATURE. POST DILATATION WAS PERFORMED WITH A 3.5X8MM QUANTUM MAVERICK BALLOON, INFLATED TO 15 ATM. THE PT EXPERIENCED CHEST PAIN FOLLOWING THE DEPLOYMENT OF THE STENT, WHICH WAS TREATED WITH INTRACORONARY VASODILATORS, VERAPAMIL, AND NITROGLYCERIN. GOOD ANGIOGRAPHIC RESULTS WERE ACHIEVED. MEDICATION GIVEN: HEPARIN AND ORAL PLAVIX. THE PT WAS DISCHARGED THE FOLLOWING DAY. THREE DAYS POST THE DEPLOYMENT OF THE STENT IN THE RCA, THE PT PRESENTED WITH CHEST PAIN. THE PT WAS GIVEN HEPARIN AND ADMITTED TO THE HOSPITAL. THE CHEST PAIN RESOLVED.

    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 3.50X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization