BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904270 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05093
    Event Type
    Death
    Date Received
    November 22, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION:SHAMMAS, NICOLAS W, MD AND GAIL A. SHAMMAS, RN; MICHAEL JERIN, PHD; ANUP PARIKH, KATERINE COIN; ERIC DIPPEL, MD; PETER SHARIS, MD; JON ROBKEN, MD. TREATMENT OF LEFT MAIN CORONARY TRIFURCATION LESIONS WITH THE PACLITAXEL DRUG-ELUTING STENT: MID-TERM OUTCOMES FROM A TERTIARY MEDICAL CENTER. J INVASIC CARDIOL 2009; 21: 321-325. IF IMPLANTED, GIVE DATE: BETWEEN (B)(6) 2006 AND (B)(6) 2007.DEVICE EVALUATED BY MANUFACTURER- IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. IF THERE IS ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED AND THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THE TARGET LESION WAS LOCATED AT A LEFT MAIN TRIFURCATION. V-STENTING WAS PERFORMED AT THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX (LCX) WITH TWO 3.5MM TAXUS STENTS. TWO ADDITIONAL TAXUS STENTS, SIZE 2.5MM, WERE PLACED AT THE RAMUS INTERMEDIUS. THE FOUR STENTS WERE POST DILATED TO 14ATMS. DURING THE PROCEDURE, THE PATIENT RECEIVED HEPARIN. PRIOR TO THE PROCEDURE THE PATIENT WAS ON CLOPIDOGREL AND ASPIRIN AND REMAINED ON THE MEDICATIONS POST PROCEDURE. FIVE MONTHS LATER, THE PATIENT SUFFERED SUDDEN CARDIAC DEATH. NO AUTOPSY WAS PERFORMED HOWEVER THE PATIENT HAD POSSIBLE ACUTE STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK432

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death