BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 739625 · Received July 20, 2006

    Report

    Report Number
    6000093-2006-01334
    Event Type
    Injury
    Date Received
    July 20, 2006
    Date of Event
    July 5, 2006
    Report Date
    July 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE STENT REMAINS IMPLANTED, AND THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 8386644 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    TAP - IT WAS REPORTED THAT 85 DAYS AFTER IMPLANTATION OF 2.5X24 MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, A 90% STENOTIC LESION AND 80% STENOTIC LESION WAS LOCATED THE MID POSTERIOR (A-V) RIGHT CORONARY ARTERY (PAV) AND THE PROXIMAL 2ND POSTEROLATERAL BRANCH ARTERY (PLB), RESPECTIVELY. NO INFO WAS REPORTED CONCERNING VESSEL TORTUOSITY OR LESION CALCIFICATION. A 2.5X24 MM TAXUS STENT WAS DEPLOYED IN THE PAV AND PLB. A POST-INTERVENTION RESULT OF 0% RESIDUAL STENOSIS WAS REPORTED FOR BOTH LESIONS. NO INFO WAS REPORTED CONCERNING MEDICATIONS. THE PT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. THE PT PRESENTED 85 DAYS AFTER THE INITIAL PROCEDURE WITH 80% IN-STENT RESTENOSIS IN THE MID PAV AND 90% IN-STENT RESTENOSIS IN THE PLB. FOLLOWING PTCA, A 2.75X32 MM TAXUS STENT WAS DEPLOYED IN THE PAV AND THE PLB IN THE REGION OF THE PREVIOUSLY PLACED 2.5X24 MM TAXUS STENT. A POST-INTERVENTION RESULT OF 0% WAS REPORTED FOR THE PAV AND THE PLB. THE PT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.50X24MM 8386644

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O