BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1181525 · Received September 25, 2008

    Report

    Report Number
    2134265-2008-02808
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MFG DOCUMENTATION FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS CONSIDERED OPERATIONAL CONTEXT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE THE PERFORMANCE OF THE DEVICE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THERE WAS STENT DAMAGE. THE LESION BEING TREATED WAS 99% STENOSED WITH CALCIFICATION IN AN EXTREMELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX TO THE POSTEROLATERAL BRANCH. A NON BSC GUIDE CATHETER DID NOT PROVIDE GOOD BACK UP AND IT WAS CHANGED TO A DIFFERENT NON BSC GUIDE CATHETER. IVUS THEN CROSSED THE LESION. FIRST, A TAXUS 3.5X24MM WAS IMPLANTED AT LCX PL FOR INSTANT RESTENOSIS OF A PREVIOUSLY IMPLANTED NON BSC STENT. THE PROXIMAL LEFT CIRCUMFLEX WAS DILATED WITH A QUANTUM MAVERICK 3.5X8MM. AN ATTEMPT WAS MADE TO IMPLANT A TAXUS 3.5X28MM, HOWEVER, IT COULD NOT CROSS THE LESION WITH THE SEVERE CALCIFICATION. SEVERAL ATTEMPTS WERE MADE AND IT WAS THEN NOTED THAT THE PROXIMAL EDGE OF THE STENT LIFTED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. PATIENT STATUS IS GOOD WITH NO COMPLICATIONS 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 3.50X28MM 0011487134

    Patients

    Seq Age Sex Outcome Treatment
    1 GC: BRITE TIP