BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 706592 · Received May 1, 2006

    Report

    Report Number
    6000089-2006-00815
    Event Type
    Injury
    Date Received
    May 1, 2006
    Date of Event
    March 28, 2006
    Report Date
    March 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 697 DAYS AFTER IMPLANTATION OF A 2.50X16 MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OMI) ARTERY. A PRE-INTERVENTION STENOSIS OS 75% AND A TIMI GRADE 3 FLOW WAS REPORTED. A 2.50X16 MM TAXUS STENT WAS DEPLOYED IN THE LESION. IT WAS NOTED THAT NO PREDILATION WAS DOCUMENTED. A POST-INTERVENTION STENOSIS OF 0% AND A TIMI GRADE 3 FLOW WAS REPORTED. THE PT RECEIVED HEPARIN AND NITRITIES DURING THE PROCEDURE. THE TARGET VESSEL WAS REPORTED NOT TO BE CALCIFIED OR TORNUOUS. THE PT WAS PLACED ON PLAVIX. ASPIRIN, ALTACE, ZOCOR, GLUCOVANCE, GLUCOPHAGE AND NITROGLYCERIN FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS FOLLOWING THE PROCEDURE. THE PT PRESENTED 697 DAYS AFTER THE INITIAL PROCEDURE WITH A 90% IN-STENT RESTENOSIS IN THE OMI. AFTER BALLOON DILATION WITH A 2.5X15 MM MAVERICK BALLOON, A 2.5X18 MM CYPHER STENT WAS DEPLOYED IN THE RESTENOTIC REGION OF THE OMI. POST-INTERVENTION OUTCOMES WERE REPORTED AS "EXCELLENT RESULTS". PT COMPLICATIONS WERE REPORTED AS "NO COMPLICATIONS." PT STATUS WAS REPORTED AS "EXCELLENT AT TIME OF DISCHARGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.50X16MM 6252186

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention