BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1941485 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05785
    Event Type
    Injury
    Date Received
    December 29, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2006. DEVICE IS 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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT THAT POST A STENTING TREATMENT PROCEDURE AN ALLERGIC REACTION AND CHEST PAIN OCCURRED. A 2.50X16MM TAXUS EXPRESS2 STENT WAS IMPLANTED IN THE ¿BACK OF THE HEART¿. ONE TO TWO WEEKS AFTER THE STENT WAS IMPLANTED THE PATIENT BEGAN TO EXPERIENCE AN ALLERGIC REACTION, A HACKING COUGH AND "BEATS OF HESITATION" CAUSING CHEST PAIN. THE PATIENT IS ALSO EXPERIENCING PAIN IN HER BACK BY HER SHOULDER BLADES. AN EKG WAS PERFORMED ON THE PATIENT WHICH REVEALED AN IRREGULAR HEART BEAT. THE PATIENT FEELS LIKE THERE IS SOMETHING STUCK BETWEEN HER CHEST AND BACK CAUSING TENSION. THE PATIENT RECALLED EXPERIENCING BACK PAIN DURING THE STENTING PROCEDURE DUE DIFFICULTY ADVANCING THE STENT AND THE PATIENT WAS ASKED TO TAKE A LOT OF DEEP BREATHES DURING THE PROCEDURE. IT WAS ALSO NOTED THAT THE PATIENT HAS THYROID PROBLEMS AND HER THYROID MEDICATION WAS CUT DOWN DUE TO THE IMPLANTED STENT. AT THE TIME OF THIS REPORT, THE PATIENT'S SYMPTOMS PERSIST. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    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 - MAPLE GROVE H7493897016250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other