BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 5418505 · Received February 9, 2016

    Report

    Report Number
    2029214-2016-00078
    Event Type
    Death
    Date Received
    February 9, 2016
    Date of Event
    December 7, 2015
    Report Date
    January 14, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL AND LOT NUMBERS WERE NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED SYMPTOMATIC INTRACRANIAL HEMORRHAGE AND THE RELATEDNESS TO THE SOLITAIRE FR DEVICE USE. SAME ARTICLE AS REPORTED IN MDR MFR # 2029214-2016-00077

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM LITERATURE REVIEW THAT OF 89 CASES, 8 PATIENTS HAD SICH AND WERE DECEASED AT 3 MONTHS. THE AUTHORS CONDUCTED A RETROSPECTIVE ANALYSIS OF CONSECUTIVE ACUTE ISCHEMIC STROKES CASES TREATED BETWEEN (B)(6) 2010 AND (B)(6) 2013 WHERE THE SOLITAIRE STENT RETRIEVER WAS USED FOR ACUTE ISCHEMIC STROKE. THE AUTHORS'S GOAL WAS TO IDENTIFY PROGNOSTIC FACTORS OF CLINICAL OUTCOME IN PATIENTS WITH ACUTE ISCHEMIC STROKE UNDERGOING THROMBECTOMY WITH SOLITAIRE RETRIEVER. CITATION: JIANG S, FEI A, PENG Y, ZHANG J, LU Y-R, WANG H-R, ET AL. (2015) PREDICTORS OF OUTCOME AND HEMORRHAGE IN PATIENTS UNDERGOING ENDOVASCULAR THERAPY WITH SOLITAIRE STENT FOR ACUTE ISCHEMIC STROKE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76721 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SOLITAIRE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death