BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1022177 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00896
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    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 DEVICE HISTORY RECORD FOR THIS PARTICULAR BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECS AT THE TIME OF RELEASE TO DISTRIBUTION. TAKING INTO CONSIDERATION THE DETAILS OF THE COMPLAINT, OPERATIONAL CONTEXT WOULD BE MOST PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2008-00897. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION WAS ROTABLATED AND PRE-DILATED, UNK TYPE AND SIZE BALLOON. THE PHYSICIAN THEN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.5X16MM DRUG ELUTING STENT TO THE MID RIGHT CORONARY ARTERY (RCA), BUT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL, IT WAS NOTED THAT THE STENT EDGES WERE FRAYED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.25X28MM DRUG ELUTING STENT TO THE MID RCA AND AGAIN WAS UNABLE TO CROSS THE LESION AND STENT DAMAGE OCCURRED. THE LESION WAS THEN PRE-DILATED WITH A QUANTUM MAVERICK 3.5X15MM BALLOON AND THE PROCEDURE WAS COMPLETED BY IMPLANTING 3 TAXUS STENTS, A 3.5X8MM, A 3.5X16MM AND A 3.5X20MM. NO PT COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS FINE.

    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 3.5X28MM 9781951

    Patients

    Seq Age Sex Outcome Treatment
    1