BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 806060 · Received January 11, 2007

    Report

    Report Number
    6000093-2007-00090
    Event Type
    Injury
    Date Received
    January 11, 2007
    Date of Event
    December 12, 2006
    Report Date
    December 13, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8180797 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    SAME CASE AS MFR'S REPORT# 6000093-2007-00091. IT WAS REPORTED THAT 90 DAYS AFTER IMPLANTATION OF TWO 3.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENTS, IN-STENT RESTENOSES OCCURRED. DURING THE INITIAL PROCEDURE, THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY TO SAPHENOUS VEIN GRAFT (RCA TO SVG). PRE-INTERVENTION IN-STENT RESTENOSES OF 90% PROXIMAL AND 70% MID WERE NOTED. THE STENT TYPE AND SIZE WERE NOT REPORTED. THE LESIONS WERE PRE-DILATED WITH A 3.5X12MM NON-BOSTON SCIENTIFIC BALLOON. A 3.5X24MM TAXUS STENT WAS DEPLOYED IN THE "MID PORTION OF THE VEIN GRAFT." A 3.5X24MM TAXUS STENT WAS THEN DEPLOYED IN THE "PROXIMAL PORTION OF THE VEIN GRAFT." BOTH STENTS WERE DILATED WITH A 4.0X9MM NON-BOSTON SCIENTIFIC BALLOON. THERE WAS "NO RESIDUAL STENOSIS AND TIMI GRADE III FLOW" POST PROCEDURE. THE RESULTS WERE NOTED TO BE "EXCELLENT." THE PT REC'D HEPARIN DURING THE PROCEDURE; PLAVIX AND ASPIRIN AFTER THE PROCEDURE. THE PT "TOLERATED THE PROCEDURE WELL." NO COMPLICATIONS WERE REPORTED. THE PT PRESENTED 90 DAYS LATER WITH "UNSTABLE ANGINA" AND A 95% IN-STENT RESTENOSIS IN THE RCA TO SVG. A 3.5X18MM NON-BOSTON SCIENTIFIC STENT WAS DEPLOYED IN THE "MID PORTION OF THE VESSEL." A 3.5X13MM NON-BOSTON SCIENTIFIC STENT WAS THEN DEPLOYED PROXIMALLY. THE STENTS WERE THEN POST-DILATED WITH A 4.0X12MM NON-BOSTON SCIENTIFIC BALLOON. A POST-INTERVENTION RESIDUAL STENOSIS OF 0% WITH TIMI GRADE III FLOW WAS REPORTED. THE PROCEDURE WAS NOTED TO BE "SUCCESSFUL." NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ: STENT, CORONARY, DRUG ELUTING NIQ BOSTON SCIENTIFIC 3.5X24MM 8180797

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R 4.0X9MM RANGER BALLOON| 3.5X12MM VOYAGER BALLOON