BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 622705 · Received July 18, 2005

    Report

    Report Number
    6000089-2005-01082
    Event Type
    Malfunction
    Date Received
    July 18, 2005
    Date of Event
    January 11, 2005
    Report Date
    June 20, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENT TREATMENT PROCEDURE A DEVICE MALFUNCTION OCCURRED. THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 3.0 MM VESSEL DIAMETER, 90% STENOSED REGION OF THE DISTAL RIGHT CORONARY ARTERY (RCA). THE TARGET LESION HAD MILD CALCIFICATION AND WAS MIDLY TORTUOUS. A THROMBUS WAS NOTED PRE-PROCEDURE. THE PHYSICIAN PREDILATED THE LESION PRIOR TO ATTEMPTING TO PLACE ONE TAXUS EXPRESS2 8.8% 2.75X16MM DRUG ELUTING STENT. DURING THE ATTEMPTED DEVICE IMPLANTATION THE DELIVERY BALLOON RUPTURED AT 12 ATMOSPHERE (ATM) AND THE STENT WAS NOT DEPLOYED. THE PHYSICIAN THEN REPLACED THE MALFUNCTIONING TAXUS SYSTEM WITH A SECOND TAXUS EXPRESS2 8.8% 2.75X16 MM (LOT 7124784) DRUG ELUTING STENT THAT WAS SUCCESSFULLY DEPLOYED. A PROXIMAL GRADE B DISSECTION WAS NOTED AS A PROCEDURE COMPLICATION. IT WAS CAUSED BY DEEP THROATING OF THE DYE CATHETER. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF ONE TAXUS EXPRESS2 8.8% 3.5X16 MM. LOT 7060492) DRUG ELUTING STENT. THE PT WAS DISCHARGED FROM THE HOSP ONE DAY LATER RECEIVING ASA AND PLAVIX.

    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% 2.75 X 16 MM 7108888

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR