BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 11385810 · Received February 26, 2021

    Report

    Report Number
    2029214-2021-00211
    Event Type
    Death
    Date Received
    February 26, 2021
    Date of Event
    January 1, 2019
    Report Date
    February 26, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    YUAN PU. COMPARISON OF DIFFERENT TYPES OF ENDOVASCULAR MECHANICAL EMBOLECTOMY IN ACUTE ISCHEMIC STROKE. REV ASSOC MED BRAS 2019; 65( 3):342-347. DOI:10.1590/1806-9282.65.3.342 SUMMARY BACKGROUND: TO COMPARE THE TREATMENT EFFICACY OF DIFFERENT TYPES OF ENDOVASCULAR MECHANICAL EMBOLECTOMY IN ACUTE ISCHEMIC STROKE (AIS). MATERIAL AND METHODS: A TOTAL OF 89 PATIENTS WITH AIS WERE SELECTED IN OUR HOSPITAL FROM JANUARY 2014 TO JANUARY 2016 AND DIVIDED INTO TPA GROUP (N=27), TPA+TREVO GROUP (N=30) AND TPA+SOLITAIRE FR GROUP (N=32) FOR DIFFERENT TREATMENTS. TREATMENT EFFECTIVENESS WAS EVALUATED USING NIHSS AND MRS SYSTEM. THE NIHSS SCORE, VASCULAR RECANALIZATION RATE AND POSTOPERATIVE COMPLICATIONS WERE COMPARED AMONG GROUPS. RESULTS: THE NIHSS SCORE OF THE TPA GROUP WAS SIGNIFICANTLY LOWER THAN THAT OF OTHER TWO GROUPS AT 1 D AFTER THE OPERATION (P < 0.05), BUT IT WAS SIGNIFICANTLY HIGHER THAN THAT OF OTHER TWO GROUPS AT 3 D AND 3 W AFTER THE OPERATION (P < 0.05). AFTER THE TREATMENT, NO SIGNIFICANT DIFFERENCE IN NIHSS SCORE WAS FOUND BETWEEN THE TPA+TREVO AND TPA SOLITAIRE FR GROUPS. THE REVASCULARIZATION RATE WAS SIGNIFICANTLY HIGHER, BUT THE MORTALITY RATE IN 90 D WAS SIGNIFICANTLY LOWER IN THE TPA+TREVO AND TPA+SOLITAIRE FR GROUPS THAN THAT IN THE TPA GROUP (P < 0.05), AND NO SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN THE TPA+TREVO AND TPA+SOLITAIRE FR GROUPS. THE INCIDENCE RATE OF SYMPTOMATIC INTRACRANIAL HEMORRHAGE WAS SIGNIFICANTLY LOWER IN THE TPA+SOLITAIRE FR GROUP THAN THAT IN TPA+TREVO GROUP (P< 0.05) OR TPA GROUP (P < 0.01). SIGNIFICANTLY MORE PATIENTS WITH MRS NO HI GHER THAN 2 POINTS WERE FOUND IN THE TPA+TREVO AND TPA+SOLITAIRE FR GROUPS THAN THOSE IN TPA GROUP (P< 0.05), AND NO SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN THE TPA+TREVO AND TPA+SOLITAIRE FR GROUPS. CONCLUSION: TPA+SOLITAIRE FR IS A TYPE OF THROMBECTOMY THAT IS SUPERIOR TO TPA AND TPA+TREVO IN THE TREATMENT OF PATIENTS WITH AIS. - MORTALITY AT 90 DAYS OCCURRED WITH 4 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283847 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SFR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death