BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 4387073 · Received January 6, 2015

    Report

    Report Number
    2029214-2014-00787
    Event Type
    Death
    Date Received
    January 6, 2015
    Date of Event
    September 4, 2013
    Report Date
    December 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS OF THE REPORTED LOT NUMBERS HAVE BEEN REVIEWED AND NO ISSUES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS IT THEY WERE DISCARDED; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS: MODEL#: SFR-6-20 / LOT#: 9632731 / DOM: 08/20/2012 EXP: 08/02/2014.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(4) CLINICAL STUDY, SUBJECT: (B)(6). ON (B)(6) 2013, THE PATIENT WAS RANDOMIZED TO IV TPA + SOLITAIRE FR AND TREATED WITH TWO SOLITAIRE DEVICES. THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION) WAS 2B AFTER THREE SOLITAIRE PASSES. ONE DAY POST PROCEDURE, IT WAS REPORTED THE PATIENT HAD AN INTRAVENTRICULAR HEMORRHAGE AND PARENCHYMAL HEMATOMA. ON (B)(6) 2013, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS SEPSIS AND IT WAS STUDY RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7187 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN SFR-4-20 9647006

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death