BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 538763 · Received August 10, 2004

    Report

    Report Number
    6000089-2004-00907
    Event Type
    Malfunction
    Date Received
    August 10, 2004
    Date of Event
    August 5, 2004
    Report Date
    August 5, 2004
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, DIFFICULTY DEFLATING THE BALLOON WAS ENCOUNTERED. THE LESION BEING TREATED WAS A 90% STENOSED, TORTUOUS, DE NOVO CIRCUMFLEX (CX) LESION WITH SOME CALCIFICATION. THE LESION WAS NOT PREDILATED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A CYPHER STENT, BUT WAS UNABLE. USING A BMW GUIDE WIRE AND A 6 FR Q GUIDE CATHETER, THE PHYSICIAN WAS ABLE TO PLACE THE TAXUS EXPRESS2 8.8% 2.5 X 12 MM DRUG ELUTING STENT WITHOUT INCIDENT. THE BALLOON INFLATED AND WAS VISIBLE UNDER FLUOROSCOPY AT 3-4 ATMS. THE TAXUS STENT WAS DEPLOYED SUCCESSFULLY. THE PHYSICIAN THEN NOTICED THAT THE BALLOON WAS DEFLATING VERY SLOWLY. THE PHYSICIAN REINFLATED AND DEFLATED THE BALLOON AND IT DID DEFLATE COMPLETELY. THE BALLOON WAS INFLATED FOR A TOTAL OF 60 SECONDS. THE PT DID NOT EXPERIENCE ANY SYMPTOMS WHILE THE BALLOON WAS INFLATED. THE BALLOON WAS REMOVED FROM THE PT INTACT AND COMPLETELY DEFLATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE CONDITION OF THE PT IS LISTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.50 X 12 MM 6634676

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention