BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 712927 · Received May 10, 2006

    Report

    Report Number
    6000093-2006-00851
    Event Type
    Injury
    Date Received
    May 10, 2006
    Date of Event
    April 10, 2006
    Report Date
    April 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 125 DAYS AFTER IMPLANTATION OF A 2.5X16 MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE 2ND POSTERIOR LEFT VENTRICLE BRANCH (PLB) OF THE RIGHT CORONARY ARTERY (RCA) A PRE-INTERVENTION STENOSIS OF 90% WAS REPORTED. FOLLOWING PERCUTANEOUS TRANSLIMINAL CORONARY AHGIOPLASTY (PTCS) A 2.5X16 MM TAXUS DRUG ELUTING STENT WAS DEPLOYED. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WAS REPORTED. NO INFORMATION CONCERNING LESION CALCIFICATION OR VESSEL TORTUOSITY WAS REPORTED. THE PT REPORTEDLY TOLERATED THE PROCEDURE "WELL." NO COMPLICATIONS WERE REPORTED. THE PT PRESENTED 125 DAYS AFTER THE INITIAL PROCEDURE WITH AN IN-STENT RESTENOSIS IN THE 2ND PLB OF THE RCA. A PRE-INTERVENTION IN-STENT RESTENOSIS OF 70% WAS REPORTED. FOLLOWING PTCA, A 2.5X6 MM TAXUS DRUG ELUTING STENT WAS DEPLOYED. A POST-INTERVENTION RESIDUAL STENT OF 0% WAS REPORTED. IT WAS ALSO NOTED THAT A 2.5X8 MM TAXUS STENT "COULD NOT BE ADVANCED INTO THE 2ND PLB OR WITHDRAWN AND WAS DEPLOYED IN MID RCA AND DILATED TO 3.0. "THE PT REPORTEDLY TOLERATED THE PROCEDURE "WELL." NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.5X16MM 7989153

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention