BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1230211 · Received November 13, 2008

    Report

    Report Number
    2134265-2008-04336
    Event Type
    Injury
    Date Received
    November 13, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATION AT THE TIME OF THE RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE IS DETERMINED TO BE ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-04338 AND 2134265-2008-04337. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, PATIENT COMPLICATIONS OCCURRED. THE PHYSICIAN IMPLANTED THREE TAXUS EXPRESS2 DRUG ELUTING STENTS, A 3.5X28MM, A 2.75X20MM AND A 3.5X20MM. POST STENT IMPLANTATION, THE PATIENT HAS EXPERIENCED THE FOLLOWING SYMPTOMS; SWEATING, WEAKNESS, NO ENERGY, NEUROPATHY AND NO FEELING IN THE TOES, IMMUNITY PROBLEMS, HPV INCREASE, CERVICAL DYSPLAGIA, THINNING HAIR, WEAK FINGERNAILS, ARM, NECK AND SHOULDER PAIN AND MUSCLES THAT KNOT UP. ADDITIONAL INFORMATION REGARDING THIS EVENT IS NOT AVAILABLE.

    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 SCIENTIFC 3.5X28MM 7182305

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other