BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 2923266 · Received February 8, 2006

    Report

    Report Number
    6000093-2006-02725
    Event Type
    Injury
    Date Received
    February 8, 2006
    Date of Event
    January 19, 2006
    Report Date
    January 23, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED AND THE FACILITY DISPOSED OF THE DELIVERY DEVICE; CONSQUENTLY, A RETURNED PRODUCT ANALYSIS WILL NOT BE POSSIBLE.

    Description of Event or Problem · 1

    TAP, IT WAS REPORTED THAT 140 DAYS AFTER IMPLANTATION OF A TAXUS EXPRESS2 2.75X12MM DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THEOSTIAL/PROXIMAL SECTION OF THE RADIAL ARTERY GRAFT TO THE POSTERIOR DESCENDING BRANCH OF THE RIGHT CORONARY ARTERY. THE GRAFT WAS REPORTED WITH A PRE-INTERVENTION STENOSIS OF 90% AND A POST INTERVENTION STENOSIS OF 0%. DEPLOYMENT OF A 2.75X12MM TAXUS STENT WAS COMPLETED AFTER ANGIOPLASTY WITH A CUTTING BALLOON. NO INFORMATION WAS REPORTED ON THE CALCIFICATION OR TORTUOSITY OF THE TREATED VESSEL. THE PATIENT RECEIVED HEPARIN DURING THE PROCEDURE AND PALVIX POST PROCEDURE. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. THE PATIENT PRESENTED 140 DAYS AFTER THE ORIGINAL INTERVENTION WITH 90-95% IN-STENT RESTENOSIS OF THE PROXIMAL SECTION OF THE RADIAL ARTERY GRAFT. DURING RE-INTERVENTION, A CYPHER STENT WAS PLACED IN THE PROXIMAL SECTION OF THE GRAFT. POST INTERVENTION STENOSIS WAS REPORTED AS 0%. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 2.75X12 7509107

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention