BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1080943 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02078
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 30, 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. A REVIEW OF THE MFG DOCUMENTATION FOR THIS PARTICULAR TOP ASSEMBLY BATCH NUMBER FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. TAKING INTO CONSIDERATION THE THOROUGH EVAL 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

    SAME CASE AS 2134265-2008-02077. IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A NON BSC 2.0 X 15 MM BALLOON. THE PHYSICIAN PLACED A TAXUS EXPRESS2 3.0 X 24 MM DRUG ELUTING STENT TO THE 90% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS, CALCIFIED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. POST DILATATION WAS PERFORMED AT 18 ATMS. A TAXUS EXPRESS2 3.0 X 16 MM DRUG ELUTING STENT WAS THEN IMPLANTED IN THE PROXIMAL LAD, OVERLAPPING THE 3.0 X 24 MM STENT. POST DILATATION WAS PERFORMED AT 18 ATMS. STENT PLACEMENT WAS CONFIRMED WITH IVUS AND THEY WERE DILATED COMPLETELY. ASPIRIN AND PLAVIX WERE ADMINISTERED DURING THIS PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. SIX HOURS POST IMPLANTATION, THE PT EXPERIENCED CHEST PAIN AND THROMBOSIS WAS CONFIRMED AT THE MID LAD. THE THROMBOSIS WAS ASPIRATED WITH A THROMBUSTER AND THE OCCLUSION WAS DILATED WITH A NON BSC BALLOON. FLOW WAS IMPROVED. IVUS CONFIRMED THAT THE STENT DILATATION WAS INCOMPLETE AT THE OCCLUSION. PLAVIX AND ASPIRIN WERE ADMINISTERED DURING THIS PROCEDURE. NO ADD'L INJURIES OR COMPLICATIONS WERE REPORTED.

    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 3.0X16MM 11389507

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention VOYAGER BALLOON