BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1061296 · Received June 13, 2008

    Report

    Report Number
    2134265-2008-01680
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-01681. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, BALLOON WITHDRAWAL DIFFICULTY, A SHAFT FRACTURE AND A SPIRAL DISSECTION OCCURRED. THE LESION WAS PRE-DILATED WITH A 2.0 MM NON BSC BALLOON. A 2.5 X 18 MM NON BSC STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN THEN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.0 X 32 MM DRUG ELUTING STENT TO THE MID RCA, BUT A SPIRAL DISSECTION OCCURRED WITH THE MACH 1 GUIDE CATHETER. THEREFORE, THE TAXUS STENT WAS DEPLOYED OVERLAPPING THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED STENT. UPON WITHDRAWAL OF THE STENT DELIVERY SYSTEM (SDS), THEY WERE UNABLE TO REMOVE THE BALLOON DUE TO STRONG RESISTANCE. THE BALLOON WAS INFLATED TWICE, BUT WAS STILL NOT ABLE TO BE REMOVED. THE PHYSICIAN THEN PULLED STRONGLY AND THE DISTAL SHAFT FRACTURED. NO ADDITIONAL PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS STABLE. CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED FOR TREATMENT OF THREE BRANCH LESIONS IN 2008. THE SURGEON PULLED THE REMAINING PART OF THE FRACTURED TAXUS SDS, BUT WAS NOT ABLE TO RETRIEVE IT. HE THEN CUT OFF THE PART OF THE SDS THAT PROTRUDED FROM THE OSTIUM OF THE CORONARY ARTERY IN THE AORTA. HOWEVER, THE DISTAL PART OF THE SDS REMAINS IN THE PT WITH NO PLAN OF REMOVING IT. THE CABG WAS COMPLETED SUCCESSFULLY AND THE PT'S CONDITION POST PROCEDURE IS STABLE.

    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 3.0 X 32 MM 11436966

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CYPHER STENT| RYUNJIN BALLOON| RUNTHROUGH GUIDEWIRE