BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1040494 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01346
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE PHYSICIAN PLACED A TAXUS EXPRESS2 3.0 X 16MM DRUG ELUTING STENT TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE STENT WAS DEPLOYED AT 9 ATMS AND POST DILATED AT 14 ATMS WITH A 3.0X15MM QUANTUM MAVERICK BALLOON. THE STENT WAS WELL POSITIONED, BUT UNDER SIZED. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS FINE. PLAVIX WAS PRESCRIBED POST PROCEDURE. THE PT WAS TAKEN OFF OF PLAVIX FOR A DENTAL VISIT AND PRESENTED TO THE EMERGENCY DEPT WITH ST ELEVATION AND THROMBOSIS WAS FOUND IN THE PREVIOUSLY PLACED TAXUS STENT. THE THROMBOSIS WAS TREATED WITH A 3.0X12MM QUANTUM MAVERICK BALLOON, AN EXPORT CATHETER AND THEN AGAIN WITH A 3.5MM QUANTUM BALLOON. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS FINE. REOPRO WAS USED PRIOR TO THE PROCEDURE. PLAVIX AND ASPIRIN WERE USED DURING THE PROCEDURE AND PRESCRIBED UPON DISCHARGE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention