BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1727182 · Received June 17, 2010

    Report

    Report Number
    2134265-2010-02800
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    August 22, 2009
    Report Date
    May 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED IN (B)(6) 2008, THE DE NOVO TARGET LESION WAS 99% STENOSED, 3.5MM IN DIAMETER AND 20MM LONG. PREDILATION AND POST DILATION WERE NOT PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. THE PATIENT WAS DISCHARGED 24 DAYS LATER WITHOUT COMPLICATIONS ON BAYASPIRIN AND PLAVIX. IN (B)(6) 2008 AND (B)(6) 2009, ANGINA SYMPTOMS WERE NOT RECOGNIZED IN THE EVALUATIONS OF FOLLOW UPS PERFORMED. PER PHYSICIAN'S COMMENTS, " THE RELATIVENESS BETWEEN THE DEATH AND THIS ADVERSE EVENT WAS DEFINITELY RELATED AND THE RELATIVENESS BETWEEN THE TARGET VESSEL AND THIS ADVERSE EVENT WAS UNKNOWN."

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT STENT THROMBOSIS OCCURRED PER ADJUDICATION RESULTS RECEIVED.

    Description of Event or Problem · 1

    (B) (4). IT WAS REPORTED THAT POST A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. DURING THE INDEX, THE PHYSICIAN IMPLANTED A 3.50X32MM TAXUS EXPRESS2 STENT IN THE MID RIGHT CORONARY ARTERY. IN (B) (6) 2009, IT WAS REPORTED THE PATIENT EXPIRED. WHILE THE PATIENT WAS GOING TO A HOSPITAL FOR DIALYTIC THERAPY, THE PATIENT DIED SUDDENLY IN A CAR. AN AUTOPSY WAS NOT PERFORMED. THE CAUSE OF DEATH IS UNKNOWN.

    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 H7493897032350 0011213764

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death