BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE

    MDR report key: 6978507 · Received October 25, 2017

    Report

    Report Number
    2029214-2017-01179
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    January 1, 2017
    Report Date
    October 25, 2017
    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

    "COMPARATIVE STUDY OF CLINICAL EFFICACY BETWEEN THE SOLITAIRE MECHANICAL THROMBECTOMY AND SELECTIVE ARTERIAL THROMBOLYSIS IN TREATMENT OF ACUTE CEREBRAL INFARCTION" XIONG BO, LI HANG, SHI SHU-GUI, GAO JIAN-JUN J REG ANAT OPER SURG 2017, 26(3) DOI: 10.11659/JJSSX.11E016046 THE SOLITAIRE DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED IN THE ARTICLE, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICES DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE; ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS OF HEMORRHAGE AFTER SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE CLINICAL SAFETY AND EFFICACY OF MECHANICAL THROMBECTOMY WITH THE SOLITAIRE COMPARED WITH SELECTIVE INTRA-ARTERIAL THROMBOLYSIS IN THE TREATMENT OF ACUTE CEREBRAL INFARCTION. THE AUTHORS REVIEWED 42 PATIENTS WHO UNDERWENT SOLITAIRE MECHANICAL THROMBECTOMY FOR ACUTE CEREBRAL INFARCTION. THE ARTICLE STATES THAT 4 OF THE 42 PATIENTS EXPERIENCED INTRACRANIAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756690 SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other