BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1994194 · Received February 16, 2011

    Report

    Report Number
    2134265-2011-00412
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(4). 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

    (B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SLOW FLOW OCCURRED. THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A 60% STENOSED AND 20MM LONG TARGET LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM AND TIMI-3 FLOW. THE LESION WAS TREATED WITH DIRECT STENTING WITH A 3.0X28MM TAXUS LIBERTE STENT AND POST DILATION WITH A NON-COMPLIANT BALLOON. FOLLOWING POST DILATION, MILD SLOW FLOW OCCURRED. THE PATIENT DEVELOPED CHEST AND JAW DISCOMFORT WHICH RESOLVED AFTER THE PROCEDURE AND ST SEGMENT ELEVATION WHICH PERSISTED FOR 10-15 MINUTES. THE PATIENT WAS TREATED WITH NITROGLYCERIN 100MCG X2, ZOFRAN 4MG, NIPRIDE 50MCG IC X5. THE PATIENT WAS ALSO GIVEN OXYGEN AND SUBLINGUAL NITROGLYCERIN. FINAL RESULTS CONFIRMED 0% RESIDUAL STENOS AND TIMI-3 FLOW. THE EVENT IS REPORTED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. IT IS THE OPINION OF THE PHYSICIAN THAT THERE IS A RELATIONSHIP BETWEEN THE TAXUS LIBERTE STUDY STENT AND THE EVENT.

    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 H7493893628300 13502578

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention