BEUDAMED
    FDA Adverse Event Death Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 4171233 · Received October 14, 2014

    Report

    Report Number
    2134265-2014-06263
    Event Type
    Death
    Date Received
    October 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2013, THE PATIENT WAS PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY THE INDEX PROCEDURE WAS PERFORMED AND UNSPECIFIED SIZE ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS IMPLANTED. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. ON AN UNSPECIFIED DATE, THE PATIENT DIED AND THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651669 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY UNK692

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death