BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    MDR report key: 734262 · Received June 26, 2006

    Report

    Report Number
    6000089-2006-01302
    Event Type
    Malfunction
    Date Received
    June 26, 2006
    Date of Event
    May 31, 2006
    Report Date
    May 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING DRUG ELUTING TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTY OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE SEVERELY BENT DIAGONAL ARTERY (DX). THE 2.5X20 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS FULLY DEPLOYED AT 9 ATMS. THE STENT BALLOON DEFLATED, BUT BALLOON WOULD NOT COME OUF OF THE STENT. THE PHYSICIAN ATTEMPTED TO "WIGGLE AND JIGGLE" THE BALLOON, INFLATED THE BALLOON UP 1 ATM AND DOWN. AFTER TEN MINS OF "WIGGLE AND JIGGLES", THE BALLOON WAS ABLE TO BE REMOVED. THE STENT REMAINED IN GOOD POSITION. PT WAS FINE DURING THIS EVENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC 2.50X20 MM 8069526

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN