BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1392116 · Received May 13, 2009

    Report

    Report Number
    2134265-2009-02188
    Event Type
    Injury
    Date Received
    May 13, 2009
    Date of Event
    December 8, 2008
    Report Date
    April 14, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT AFTER A CORONARY ARTERY STENTING PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 90% STENOSIS, WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE PHYSICIAN TREATED THE TARGET LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.75MM X 24MM TAXUS LIBERTE' STUDY STENT WITH 10% RESIDUAL STENOSIS. THE PATIENT HAD A NON-TARGET LESION LOCATED IN THE DISTAL CIRCUMFLEX TREATED WITH AN UNSPECIFIED NON-STUDY STENT DURING THE INDEX PROCEDURE. THE PATIENT WAS DISCHARGED THE NEXT DAY ON PROTOCOL DOSES OF ASPIRIN AND CLOPIDOGREL. IN 2008, THE PATIENT WAS SEEN IN THE CARDIOLOGY OFFICE FOR AN ANNUAL EVAL AND THALLIUM GXT. THE THALLIUM GXT REVEALED INFERO-LATERAL ISCHEMIA; EF 66%. ABOUT 1421 DAYS AFTER THE INDEX PROCEDURE THE PATIENT PRESENTED TO THE HOSPITAL FOR CARDIAC CATHETERIZATION USING LEFT RADIAL APPROACH. TREATMENT CONSISTED OF PLACEMENT OF A 3.0 X 32MM TAXUS LIBERTE STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) AND PLACEMENT OF A 3.0 X 12MM TAXUS LIBERTE STENT IN THE OSTIAL LESION. RESIDUAL STENOSIS WAS 10-15% IN THE PROX RCA AND 0% RESIDUAL IN THE OSTIUM. THE PATIENT EXPERIENCED INCREASING BLOOD PRESSURES OVERNIGHT WHICH WERE TREATED WITH BENAZEPRIL (LOTENSIN) AND BETA-BLOCKERS. THE ANGIOGRAPHIC CORE LAB REPORT, INDICATED A 22.87% STENOSIS OF THE MID RCA WITH THE COMMENT "STUDY STENT PATENT. REMOTE TVR TO PROX RCA LESION." THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.75X24MM 6828478

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R