BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 13502533 · Received February 9, 2022

    Report

    Report Number
    2029214-2022-00195
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    June 29, 2021
    Report Date
    February 9, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LI Z, ZHANG H, HAN J, ET AL. TIME COURSE AND CLINICAL RELEVANCE OF NEUROLOGICAL DETERIORATION AFTER ENDOVASCULAR RECANALIZATION THERAPY FOR ANTERIOR CIRCULATION LARGE VESSEL OCCLUSION STROKE. FRONTIERS IN AGING NEUROSCIENCE. 2021;13:651614. DOI:10.3389/FNAGI.2021.651614. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LI Z, ZHANG H, HAN J, ET AL. TIME COURSE AND CLINICAL RELEVANCE OF NEUROLOGICAL DETERIORATION AFTER ENDOVASCULAR RECANALIZATION THERAPY FOR ANTERIOR CIRCULATION LARGE VESSEL OCCLUSION STROKE. FRONTIERS IN AGING NEUROSCIENCE. 2021;13:651614. DOI:10.3389/FNAGI.2021.651614. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH A SOLITAIRE DEVICE. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE TIME COURSE AND CLINICAL RELEVANCE OF NEUROLOGICAL DETERIORATION (ND) AFTER ENDOVASCULAR RECANALIZATION THERAPY (EVT). THERE WERE 343 PATIENTS INCLUDED IN THE STUDY (155 FEMALE, MEAN AGE 68.5 YEARS). THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -129 PATIENTS EXPERIENCED NEUROLOGICAL DETERIORATION, WHICH WAS DEFINED AS AN INCREASE OF FOUR POINTS OR MORE IN THE NIHSS SCORE COMPARED TO THE BEST NEUROLOGICAL STATUS DURING HOSPITALIZATION. OF THESE, 94 WERE TREATED WITH A SOLITAIRE FIRST DURING EVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895657 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other