BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIQ STENT, CORONARY, DRUG-ELUTING

    MDR report key: 1273068 · Received December 22, 2008

    Report

    Report Number
    2134265-2008-04876
    Event Type
    Injury
    Date Received
    December 22, 2008
    Date of Event
    November 25, 2008
    Report Date
    November 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHETHER THE STENT IS A TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM OR A TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM. 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 INFO 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, AN ANEURYSM OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS BROUGHT BACK AS THEY WERE SUFFERING CHEST PAIN. ANGIOGRAPHY IDENTIFIED AN ANEURISM AT THE DISTAL END ON THE IMPLANTED 'TAXUS' STENT. THE STENT WAS THOUGHT TO BE SIZED CORRECTLY. IT IS UNKNOWN IF FURTHER INTERVENTION WAS PERFORMED. PATIENT STATUS REPORTED AS "STABLE". ADDITIONAL INFO WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other