BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE

    MDR report key: 740356 · Received May 30, 2006

    Report

    Report Number
    6000093-2006-01002
    Event Type
    Malfunction
    Date Received
    May 30, 2006
    Date of Event
    April 29, 2006
    Report Date
    May 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED. THE DELIVERY DEVICE WAS DISPOSED, AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THE SHOP FLOOR PAPERWORK (SFP) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. TE SFP REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A CORONARY STENTING DRUG ELUTING TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTY OCCURRED. THE TOTALLY OBSTRUCTED LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED, MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED TWEICE WITH A 2 .0X12MM MAVERICK BALLOON AT 12 ATMS FOR 15 SECONDS. A 2.5 X 24MM TAXUS EXPRESS2 DURG ELUTING STENT WAS FULLY DEPLOYED AT APPROXIMATELY 14-15 ATMS. THE DELIVERY BALLOON WAS COMPLETELY DEFLATED, BUT THE PHYSICIAN WAS UNABLE TO REMOVED IT FROM THE STENT. AFTER THREE TO FOUR MINUTES OF UNSUCCESSFUL MANEUVERS, THE GUIDE WAS DEEP SEATED, REMOVING THE BALLOON , INTACT, FROM THE STENT. THE STENT REMAINED IN POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE OCCURRED. PATIENT STATUS REPORTED AS "GOOD/STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STE DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2 . 50X24 MM 8444697

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR