BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS® EXPRESS²®

    MDR report key: 3123056 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03214
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    March 17, 2012
    Report Date
    April 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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#: 2134265-2013-03213, 2134265-2013-03215 IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. IN (B)(6) 2008, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (DIST LAD). THE TARGET LESION WAS TREATED WITH PLACEMENT OF THREE TAXUS EXPRESS2 STENTS OF SIZE 3.50X12MM, 2.75X32MM AND 3.00X16MM. IN (B)(6) 2012, THE PATIENT WAS FOUND IN CARDIAC OR RESPIRATORY ARREST AND THEN EXPIRED UNEXPECTEDLY. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223809 TAXUS® EXPRESS²® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493897032270 11428199

    Patients

    Seq Age Sex Outcome Treatment
    1 Death