BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902593 · Received November 18, 2010

    Report

    Report Number
    2134265-2010-05202
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - IT IS 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. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ONE DAY LATER THE PATIENT EXPERIENCED CHEST PAIN ONCE DURING FOLLOW-UP. THE SYMPTOM WAS RESOLVED WITH NO ACTION TAKEN.

    Description of Event or Problem · 1

    TAXUS EXPRESS2 (B)(6) STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). DETAILS OF THE LESION ARE UNKNOWN. THE PHYSICIAN IMPLANTED A 3.00X16MM TAXUS EXPRESS2 STENT TO THE PROXIMAL LAD. DURING A 2-YEAR FOLLOW-UP, THE PHYSICIAN FOUND THAT THE PATIENT'S ANGINAL SYMPTOMS CHANGED FOR THE WORSE THAN THE PREVIOUS 1 YEAR FOLLOW-UP PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897016300 11598973

    Patients

    Seq Age Sex Outcome Treatment
    1 Other