BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2143311 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02491
    Event Type
    Death
    Date Received
    June 28, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-02494. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A VESSEL DISSECTION OCCURRED AND THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY (CX). THERE WERE TWO LESIONS IN THE CX AND THE PHYSICIAN ADVANCED AN ION STENT DELIVERY SYSTEM (SDS) TO THE DISTAL LESION AND DEPLOYED THE STENT. THE PHYSICIAN ATTEMPTED TO DELIVER ANOTHER ION SDS PROXIMAL TO THE FIRST PLACED STENT AND IT WAS NOTED THAT THE PATIENT'S VITAL SIGNS WERE NOT GOOD. ANGIOGRAM WAS PERFORMED AND A DISSECTION WAS NOTED IN THE LEFT MAIN (LM). THE PHYSICIAN ATTEMPTED TO STABILIZE THE PATIENT BY TREATING THE DISSECTION; HOWEVER, THE PATIENT EXPIRED. THE PATIENT'S CAUSE OF DEATH IS LISTED AS CARDIAC RESPIRATORY DISTRESS DUE TO A DISSECTION IN THE LM AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R ION STENT