BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1002354 · Received February 22, 2008

    Report

    Report Number
    2134265-2008-00539
    Event Type
    Death
    Date Received
    February 22, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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

    SAME CASE AS MFR REPORT #2134265-2008-00528. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE, DEATH OCCURRED. THE PROCEDURE WAS EMERGENT DUE TO ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE 100% STENOSED, ECCENTRIC, DE NOVO LESION, WAS IN THE LEFT CIRCUMFLEX (LCX) ARTERY. ACCESS TO THE LESION WAS OBTAINED VIA THE TRANSRADIAL APPROACH USING A UNK TYPE 6F RADIAL GUIDE CATHETER. A 3.0X20MM TAXUS DRUG ELUTING STENT (DES) WAS DEPLOYED IN THE TARGET LESION. A 3.0X15MM QUANTUM MAVERICK BALLOON WAS USED TO POST DILATE THE STENT. A PT2 GUIDEWIRE WAS USED IN THE PROCEDURE AND THE GUIDEWIRE "BROKE IN THE FIRST OBTUSE MARGINAL AFTER KISSING BALLOON." IT IS UNK WHEN DURING THE PROCEDURE THE PT2 GUIDEWIRE BREAKAGE OCCURRED. THE BREAK OCCURRED IN THE DISTAL PORTION OF THE PT2 GUIDEWIRE AND THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE AS A UNIT. AN UNSUCCESSFUL ATTEMPT AT RETRIEVING THE SEPARATED WAS PERFORMED. AT AN UNSPECIFIED TIME, THE PT DIED. THE REPORTED CAUSE OF DEATH WAS STEMI. THE RELATIONSHIP OF THE TAXUS DEVICE TO THE PT'S DEATH IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED.

    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 3.0X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death