BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1191872 · Received October 1, 2008

    Report

    Report Number
    2134265-2008-02852
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFG RECORDS FOR THIS BATCH HAVE BEEN REVIEWED, AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. PRODUCT ANALYSIS FOUND THAT THE TIP WAS SLIGHTLY FLARED AND THE STENT WAS NO LONGER PRESENT ON THE DELIVERY SYSTEM. THE RETURNED CATHETER WAS VISUALLY, TACTILELY EXAMINED ALONG THE ENTIRE LENGTH AND THE ONLY DAMAGE SEEN WAS ON THE DISTAL END. THE DISTAL END WAS FURTHER INSPECTED UNDER MAGNIFICATION. IT WAS NOTED THAT THE BALLOON HAD STARTED TO UNWRAP INDICATING THAT THE SYSTEM HAD BEEN EXPOSED TO POSITIVE PRESSURE. THE STENT IMPRESSION COULD STILL BE SEEN ON THE BALLOON, HOWEVER, IT WAS DIFFICULT TO VERIFY PLACEMENT OF THE STENT WITH RESPECT TO THE MARKER BANDS DUE TO THE BALLOON UNFOLDING. THE STENT WAS NOT RETURNED WITH THE DEVICE FOR ANALYSIS. IT WAS NOT POSSIBLE TO DETERMINE HOW OR WHEN THE DAMAGE OCCURRED ON THE DELIVERY SYSTEM. THEREFORE THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WILL BE CONSIDERED OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, THE STENT CAME OFF OF THE BALLOON DURING REMOVAL FROM THE PT. ANGIOGRAPHY SHOWED THE PT HAD 95% STENOSIS IN THE MID RCA (RIGHT CORONARY ARTERY) AND SEVERE CALCIFICATION. PREDILATATION WAS PERFORMED USING A 3.0 X20MM MAVERICK2 BALLOON. THE PHYSICIAN ATTEMPTED TO IMPLANT A 4.5X16MM TAXUS EXPRESS2 DRUG ELUTING STENT IN THE MID RCA, BUT IT COULD NOT CROSS THE LESION. THREE ATTEMPTS WERE MADE TO CROSS THE LESION. WHILE RETRIEVING THE STENT, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE PHYSICIAN PULLED THE STENT BACK INTO THE CATHETER AND SUCCESSFULLY REMOVED THE DEVICE. THE 4.5 X 16 MM DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 4.5X 20 MM TAXUS STENT. IT WAS ALSO REPORTED THAT THE STENT WAS LOST DURING THE DISINFECTION PROCESS AT THE HOSPITAL AND COULD NOT BE RETURNED WITH THE DELIVERY SYSTEM.

    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 CORPORATION 4.5X16MM 11049049

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR