BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1143690 · Received August 29, 2008

    Report

    Report Number
    2134265-2008-02481
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    June 2, 2008
    Report Date
    August 5, 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

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A BATCH NUMBER OF THIS COMPLAINT IS UNK. A SHIP HISTORY PERFORMED IDENTIFIED NO POTENTIAL BATCHES SOLD TO THIS CUSTOMER. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS DETERMINED TO BE 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 2134265-2008-02482. IT WAS REPORTED THAT A POST CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A NON BSC BALLOON, UNK SIZE. THE PHYSICIAN PLACED TWO TAXUS EXPRESS2 DRUG ELUTING STENTS TO THE 90% STENOSED LESION LOCATED IN THE NONCALCIFIED, MODERATELY TORTUOUS, MID TO DISTAL RIGHT CORONARY ARTERY (RCA), A 3.0X16MM AND A 2.75X20MM. BOTH STENTS WERE POST DILATED AT 14 ATMS WITH A NON BSC BALLOON, UNK SIZE. POST IVUS CONFIRMED THAT THE STENTS WERE WELL POSITIONED AND WELL APPOSED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. FIVE MONTHS POST PROCEDURE THE PT EXPERIENCED CHEST PAIN AND PRESENTED TO THE HOSPITAL WITH A DECREASED LEVEL OF CONSCIOUSNESS. ANGIOGRAPHY CONFIRMED THROMBOSIS INSIDE THE PREVIOUSLY PLACED STENTS. THE THROMBUS WAS ASPIRATED WITH A REVERSE CATHETER. DILATATION WAS PERFORMED WITH A 3.5MM BALLOON CATHETER, UNK TYPE. A TAXUS EXPRESS2 STENT WAS THEN IMPLANTED IN THE DISTAL PORTION OF THE STENTS. TIMI III FLOW WAS ACHIEVED. NO ADD'L' PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS STABLE. THE PHYSICIAN REPORTED THAT THE PT HAD BEEN TAKING PANALDINE AND BAYASPIRIN AS PRESCRIBED.

    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 2.75X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention