BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1153345 · Received September 5, 2008

    Report

    Report Number
    2134265-2008-02549
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 7, 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 NO DEVICE WAS RECEIVED FOR ANALYSIS IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THERE WAS NO INDICATION OF A MANUFACTURING DEFECT OR ANOMALY IDENTIFIED WITHIN THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED BATCH NUMBER. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE PT PRESENTED WITH AN ACUTE MI AND WAS TAKEN EMERGENTLY TO THE CCL. THE 100% STENOSED LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED AND A TAXUS EXPRESS2 3.5X20MM DRUG ELUTING STENT WAS DEPLOYED AT 12 ATM'S. NO COMPLICATIONS OCCURRED. THE PT WAS INSTRUCTED TO TAKE ASPIRIN AND PLAVIX. THE PT RETURNED 16 DAYS LATER WITH A TOTAL OCCLUSION OF THE DISTAL RCA. A THROMBOSIS WAS IDENTIFIED IN THE TAXUS EXPRESS2 STENT. THE EKG WAS "STABLE" AND REINTERVENTION WAS SCHEDULED ONE WEEK LATER. THE PT RETURNED TO THE CCL AS SCHEDULED AND THE THROMBUS WAS REMOVED WITH A THROMBECTOMY DEVICE AND DILATED WITH A 3.0X20MM MAVERICK BALLOON INFLATED TWICE TO 10 AND 20 ATM'S. A 3.5X12MM NON-BSC STENT WAS PLACED, OVERLAPPING THE PROXIMAL PORTION OF THE TAXUS EXPRESS2 STENT. THE FLOW WAS ADEQUATE AND THE PROCEDURE WAS COMPLETE. THE PT WAS PRESCRIBED PLETAAL AND CONTINUED ASPIRIN AND PLAVIX. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE TAXUS EXPRESS2 STENT IS UNK.

    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 3.5X20MM 11112834

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention