BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAZEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1234055 · Received November 4, 2008

    Report

    Report Number
    2134265-2008-04199
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS OUTLINED WITH IN THE DIRECTIONS FOR USE THE DEVICE CARRIES AS ASSOCIATED RISK OF ACUTE, SUBACUTE OR LATE THROMBOSIS, VASCULAR COMPLICATIONS, AND/OR BLEEDING EVENTS. THEREFORE, THE PT SHOULD BE CAREFULLY SELECTED, AND ANTIPLATELET THERAPY BE PRESCRIBED FOR A PERIOD OF 6 MONTHS POST PROCEDURE. FAILURE TO ADHERE TO THESE INSTRUCTIONS COULD BE A POTENTIAL FOR A THROMBOTIC EVENT OCCURRING. IT IS NOTABLE THAT THERE IS NO EVIDENCE THAT INDICATES THE STENT INVOLVED IN THIS EVENT MALFUNCTIONED, OR IN SOME WAY DID NOT PERFORM TO SPEC THAT MAY HAVE RESULTED IN THIS EFFECT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE 99% STENOSED OSTIAL LESION BEING TREATED WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH 2.0X6 NON-BSC BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.50X12MM TAXUS EXPRESS2 DRUG ELUTING STENT, BUT WAS UNABLE TO CROSS THE LESION. ADD'L INFLATIONS WERE MADE WITH A 2.5X8MM QUANTUM BALLOON AND THE 2.5X12 TAXUS STENT WAS DEPLOYED AT 16 ATM FOR 30 SECONDS. THE STENT WAS POST DILATED WITH A 3.0X8MM QUANTUM MAVERICK BALLOON. THE STENT WAS WELL APPOSED WITH TIMI FLOW 3. THREE YEARS AND FOURS MONTHS POST THE INITIAL PROCEDURE, PRESENTED WITH CHEST PAIN AND THROMBOSIS WAS NOTED. AN INTERMITTENT 2ND DEGREE HEART BLOCK TYPE I WAS NOTED ON THE MONITOR. INFLATIONS WERE MADE IN THE RCA USING A 2.0X12MM AND A 3.0X12MM NON-BSC BALLOON. THE PT CONDITION WAS REPORTED AS 'FINE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAZEL-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.5X12MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SPRINTER BALLOON