BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003019 · Received February 28, 2011

    Report

    Report Number
    2134265-2011-00565
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    July 17, 2007
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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, STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED DUE TO AN ACUTE INFERIOR WALL MYOCARDIAL INFARCTION AND UNDERWENT CARDIAC CATHETERIZATION. DURING THIS PROCEDURE, THE PATIENT HAD AN UNKNOWN SIZE TAXUS EXPRESS2 STENT IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A NON-BSC STENT IMPLANTED IN THE DISTAL RCA. (B)(6) 2007, THE PATIENT EXPERIENCED THROMBOSIS AT THE SITE OF THE STENTS IN THE RCA WHICH REQUIRED MEDICAL INTERVENTION.

    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 UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CYPHER STENT