BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 2942091 · Received February 4, 2013

    Report

    Report Number
    2134265-2013-00227
    Event Type
    Death
    Date Received
    February 4, 2013
    Date of Event
    April 29, 2011
    Report Date
    January 7, 2013
    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 DEVICE EVALUATED BY MFR: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2013-00229. IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE LESION BEING TREATED WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). THE TARGET LESION WAS TREATED WITH PLACEMENT OF TWO TAXUS EXPRESS2 STENT OF SIZE 3.50X20MM AND 3.50X32MM. IN (B)(6) 2011, THE PATIENT DEVELOPED SUSPECTED ACUTE MYOCARDIAL INFARCTION AND DIED ON THE SAME DATE. NO AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46043 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493897032350 9637367

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death