BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1081432 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02087
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    August 22, 2005
    Report Date
    June 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST DISCOMFORT AND WAS ADMITTED TO THE HOSPITAL. THE FOLLOWING DAY, THE PATIENT WAS BROUGHT TO THE CCL WHERE A DISCRETE LESION WAS IDENTIFIED IN THE DISTAL POSTERIOR LATERAL BRANCH (PLB). BALLOON ANGIOPLASTY WAS PERFORMED AND A TAXUS EXPRESS2 2.5 X 16 MM DRUG ELUTING STENT WAS IMPLANTED, REDUCING THE LESION FROM 80% TO 0%. NO COMPLICATIONS OCCURRED. FOUR MONTHS LATER, THE PATIENT PRESENTED WITH LEFT ARM PAIN AND TINGLING. MEDICATIONS INCLUDED PLAVIX. A STRESS ECHOCARDIOGRAM WAS POSITIVE AND THE PATIENT WAS BROUGHT BACK TO THE CCL THE FOLLOWING DAY, FOR A REPEAT CARDIAC CATH. THE STENT WAS VISUALIZED IN THE DISTAL PLB. SEVERE DIFFUSE IN-STENT RESTENOSIS OF 99.9% WITH SUBTOTAL OCCLUSION OF THE POSTEROLATERAL ARTERY WAS DISCOVERED. DISTAL TO THE STENT, THE POSTEROLATERAL ARTERY WAS A VERY SMALL VESSEL. THE PHYSICIAN INDICATED THAT THE PATIENT WAS NOT A SUITABLE CANDIDATE FOR REPEAT INTERVENTION BECAUSE OF THE VERY SMALL NATURE AND DISTAL NATURE OF THE DISEASE. THE PLAN WAS TO TREAT THE PATIENT MEDICALLY. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 2.5X16MM 7287692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other