BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1022187 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00890
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A DETAILED DEVICE ANALYSIS THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS AND INITIAL VISUAL EXAMINATION OF THE RETURNED UNIT FOUND TIP DAMAGE. THE TIP WAS SLIGHTLY FLARED OUTWARDLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH GUIDEWIRE MOVEMENT. THE DEVICE WAS RETURNED WITHOUT THE PRODUCT MANDREL INSERTED. THE PROTECTIVE HOOP AND BALLOON/STENT PROTECTOR WERE NOT RETURNED THEREFORE, INDICATING THAT THE DEVICE HAD BEEN PREPPED FOR USE. SLIGHT KINKS WERE FOUND ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. MICROSCOPIC EXAMINATION OF THE CRIMPED STENT REVEALED THAT THE STENT HAD MOVED PROXIMALLY ON THE BALLOON. SOLIDIFIED CONTRAST MEDIA WAS PRESENT INSIDE THE INFLATION LUMEN OF THE DEVICE. IT WAS NOT POSSIBLE TO INSERT THE RECOMMENDED SIZED GUIDEWIRE (0.014 INCH) THROUGH THE LUMEN OF THE DEVICE DUE TO THE PRESENCE OF SOLIDIFIED CONTRAST MEDIA FOUND INSIDE THE INFLATION LUMEN OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. TAKING INTO CONSIDERATION THE THOROUGH EVALUATION CONDUCTED THE DETAILS OF THE COMPLAINT, HANDLING DAMAGE WOULD BE THE MOST PROBABLE ROOT CAUSE. THE COMPLAINT WAS CAUSED BY HANDLING OF THE DEVICE WITHOUT PT CONTACT DURING THE UNPACKAGING/PREPARATION.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 3/19/2008. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE 3.00X16MM TAXUS EXPRESS2 DRUG ELUTING STENT WOULD NOT LOAD ONTO THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS STENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "FINE". HOWEVER, THE RETURNED PRODUCT REVEALED THE STENT HAD MOVED ON THE BALLOON.

    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 3.00X16MM 9384734

    Patients

    Seq Age Sex Outcome Treatment
    1