BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT

    MDR report key: 766330 · Received September 29, 2006

    Report

    Report Number
    6000093-2006-01980
    Event Type
    Injury
    Date Received
    September 29, 2006
    Date of Event
    August 31, 2006
    Report Date
    September 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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. BECAUSE THE BATCH NUMBER FOR THE STENT INVOLVED IN THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 273 DAYS AFTER IMPLANTATION OF A 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, AN IN-STENT RESTENOSIS OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESION WAS LOCATED IN THE 2ND OBTUSE MARGINAL (OM-2) BRANCH OF THE LEFT CIRCUMFLEX ARTERY (LCX). A PRE-INTERVENTION STENOSIS OF 90%, "JUST DISTAL TO THE TAKEOFF OF THE FIRST OBTUSE MARGINAL ARTERY," WAS REPORTED. IT WAS NOT REPORTED THAT THE LESION WAS PRE-DILATED. A 3.0X12MM TAXUS STENT WAS DEPLOYED AT 14 ATM IN THE OM-2 IN THE REGION OF THE LESION . THE STENT WAS PLACED "ACROSS" THE OM-2/OM-1 "TAKEOFF" POINT. IT WAS ALSO NOTED THAT THE 1ST OBTUSE MARGINAL (OM-1) ARTERY HAD "MINIMAL NARROWING." PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE OM-1 WAS ATTEMPTED, BUT UNSUCCESSFUL DUE TO INABILITY TO CROSS THE VESSEL. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% IN THE OM-2 WAS REPORTED. TIMI GRADE III FLOW WAS NOTED IN THE OM-1. THE PATIENT PRESENTED 273 DAYS AFTER THE INITIAL PROCEDURE WITH A 70-80% IN -STENT RESTENOSIS IN THE "LEFT CIRCUMFLEX PROPER WITH TIMI GRADE II FLOW IN THE OM-1." THE LESION WAS PRE-DILATED WITH A 2.5X20MM MAVERICK BALLOON. AN ATHERECTOMY WAS PERFORMED ON THE MID LCX USING A 3.0X10MM CUTTING BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI GRADE III FLOW WAS REPORTED. THE PCI WAS NOTED TO BE "SUCCESSFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 DRUG-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 3. 0X12MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R