BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1012349 · Received February 12, 2008

    Report

    Report Number
    2134265-2008-00745
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    June 7, 2007
    Report Date
    February 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    OLYMPIA EU REGISTRY. IT WAS REPORTED THAT 258 DAYS FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT UNDERWENT A REINTERVENTION. THE INDEX PROCEDURE IDENTIFIED AND TREATED THREE TARGET LESION. TARGET LESION 1 WAS A DE NOVO, 3.5X12MM MODERATELY CALCIFIED, MODERATELY TORTUOUS, 80% STENOSED LESION LOCATED IN THE PROXIMAL LAD (LEFT ANTERIOR DESCENDING). TARGET LESION ONE WAS TREATED WITH PREDILATION AND PLACEMENT OF 3.5X20MM TAXUS LIBERTE RESULTING IN 15% RESIDUAL STENOSIS. TARGET LESION 2 WAS A DE NOVO, 2.5X10MM LESION WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY, AND 75% STENOSIS OF THE PROXIMAL CX (CIRCUMFLEX). TARGET LESION 2 WAS TREATED WITH PREDILATION AND PLACEMENT OF 2.5X16MM TAXUS LIBERTE RESULTING IN 10% RESIDUAL STENOSIS. A TAXUS EXPRESS2 DRUG ELUTING STENT WAS ALSO PLACED IN OM1 (1ST OBTUSE MARGINAL). THE PATIENT DISCHARGED THREE DAYS POST PROCEDURE ON ASA AND PLAVIX. AT REINTERVENTION 258 DAYS FOLLOWING THE INITIAL PROCEDURE, 80% FOCAL IN-STENT RESTENOSIS OF THE PROXIMAL LAD WAS FOUND. TREATMENT CONSISTED OF CABG (CORONARY ARTERY BYPASS GRAFTING) OF CX, LAD, AND RCA (RIGHT CORONARY ARTERY) AND WAS REPORTED AS RESOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE TAXUS LIBERTE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ - STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R