BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1071633 · Received July 9, 2008

    Report

    Report Number
    2134265-2008-01908
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 17, 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

    Additional Manufacturer Narrative · 1

    AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. THE BATCH NUMBER OF THIS COMPLAINT IS UNKNOWN. A SHIP HISTORY PERFORMED IDENTIFIED NO POTENTIAL BATCHES SOLD TO THIS CUSTOMER. TAKING INTO CONSIDERATION THE THOROUGH EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THIS INVESTIGATION WILL BE ASSIGNED THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATION AS THE DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU, AND/OR DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, HEMATOMA AND A STENOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A NON BSC 1.25X10MM BALLOON. THE PHYSICIAN IMPLANTED A TAXUS EXPRESS2 3.0X28MM DRUG ELUTING STENT TO THE 100% STENOSED LESION LOCATED IN THE NONCALCIFIED, SEVERELY TORTUOUS, MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO CROSS THE 100% STENOSED LESION WITH TWO DIFFERENT GUIDEWIRES. THE OSTIUM OF THE LESION WAS EVENTUALLY CROSSED, BUT A DISSECTION OCCURRED. THE PHYSICIAN THEN DILATED AGAIN WITH A 1.25X10MM NON BSC BALLOON AT 12 ATMS NINE TIMES. THE TAXUS STENT WAS DEPLOYED AT 11 ATMS. IVUS WAS PERFORMED AND CONFIRMED A HEMATOMA AT THE DISSECTION. IT IS THE PHYSICIAN'S OPINION THAT THE DISSECTION WAS RELATED TO THE WIRE AND DURING CROSSING ATTEMPTS THE WIRE MAY HAVE BEEN INSERTED INTO A FALSE LUMEN. BAYASPIRIN AND PLAVIX WERE PRESCRIBED TWO WEEKS PRIOR TO THIS PROCEDURE. NO ADDITIONAL PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. NINE DAYS POST PROCEDURE THE PATIENT PRESENTED WITH CHEST PAIN AND ANGIOGRAPHY CONFIRMED TOTAL STENOSIS OF THE PREVIOUSLY PLACED TAXUS STENT. AN ADDITIONAL PROCEDURE WILL BE PERFORMED FOR TREATMENT, BUT HAS NOT YET BEEN SCHEDULED.

    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 3.0X28MM

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other EXCELSIOR GUIDEWIRE| MIRACLE GUIDEWIRE| SPEEDER BALLOON