BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1934754 · Received December 21, 2010

    Report

    Report Number
    2134265-2010-05594
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT POST A STENTING TREATMENT PROCEDURE, A VESSEL OCCLUSION, ANGINA, AND SHORTNESS OF BREATH OCCURRED. IN (B)(4) 2010, THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN IMPLANTED A 2.75X32MM TAXUS LIBERTE STENT. SUBSEQUENT TO THE IMPLANT PROCEDURE, THE PATIENT HAS EXPERIENCED "UNUSUAL OUTCOMES AND SUBSEQUENT MALADIES". IN (B)(6) 2010, THE PATIENT WAS ADMITTED AND FOUND TO HAVE A 90% OCCLUSION OF THE PREVIOUSLY IMPLANTED 2.75X32MM TAXUS LIBERTE STENT. THE OCCLUSION WAS REPORTED AS "SCAR TISSUE". THE PHYSICIAN IMPLANTED A 3.50X33MM NON-BSC STENT IN THE LAD. THE PATIENT HAS NOT "RECOVERED WELL AND CONTINUES TO HAVE SHORTNESS OF BREATH AND ANGINA". ADDITIONAL TESTING HAS VERIFIED THE PATIENTS HEART IS "OK". PATIENT HAS RECEIVED A WORKING DIAGNOSIS OF MYESTHENIA GRAVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893732270 12799000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention