BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 786897 · Received November 21, 2006

    Report

    Report Number
    6000089-2006-02460
    Event Type
    Injury
    Date Received
    November 21, 2006
    Date of Event
    September 15, 2005
    Report Date
    October 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    PMA / PMN Number
    p030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: A UNIT HAS NOT BEEN RETURNED FOR REVIEW THEREFORE A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED UNIT IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS PARTICULAR BATCH NAMELY TOP ASSEMBLY BATCH # 6854665 FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS, AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE CANNOT BE DETERMINED. THESE COMPLAINTS ARE TRENDED ON A MONTHLY BASIS.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX, THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION (TVR). THE INDEX PROCEDURE TREATED 3 TARGET LESIONS. TARGET LESION #1 WAS A DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX (CX). THE LESION WAS 2.5MM WIDE, 19MM LONG AND 80% STENOSED. THERE WAS MILD CALCIFICATION AND TORTUOSITY. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 3.0X12MM TAXUS EXPRESS2 DRUG ELUTING STENT. RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS A DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 2.5MM WIDE, 20MM LONG AND 99% STENOSED. THERE WAS MILD CALCIFICATION AND TORTUOSITY. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 2.75X24MM TAXUS EXPRESS2 DRUG ELUTING STENT. RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS A DE NOVO LESION IN THE PROXIMAL RCA. THE LESION WAS 2.75MM WIDE, 16MM LONG AND 80% STENOSED. THERE WAS MILD TORTUOUSITY. THE PHYSICIAN DIRECT STENTED THE LESION WITH A 2.75X20MM TAXUS EXPRESS2 DRUG ELUTING STENT. RESIDUAL STENOSIS WAS 0%. THE PATIENT RECEIVED ANGIOMAX, ASPIRIN AND PLAVIX DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED ONE DAY LATER ON ASPIRIN AND PLAVIX. ON DAY 311, THE PATIENT HAD FOCAL IN-STENT RESTENOSIS IN THE MID RCA STENT. A TAXUS EXPRESS2 STENT WAS PLACED IN THE MID RCA. THE PATIENT WAS DISCHARGED ONE DAY LATER. IN THE OPINION OF THE PHYSICIAN, THERE WAS A PROBABLE RELATIONSHIP BETWEEN THE TVR AND THE TAXUS EXPRESS2 STENT.

    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 CORP. 2.75X24MM 6851665

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R