BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 10492228 · Received September 3, 2020

    Report

    Report Number
    2029214-2020-00890
    Event Type
    Death
    Date Received
    September 3, 2020
    Date of Event
    January 1, 2018
    Report Date
    September 3, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ZAIDAT OO, CASTONGUAY AC, GUPTA R, ET AL. NORTH AMERICAN SOLITAIRE STENT RETRIEVER ACUTE STROKE REGISTRY: POST-MARKETING REVASCULARIZATION AND CLINICAL OUTCOME RESULTS. JOURNAL OF NEUROINTERVENTIONAL SURGERY. 2018;10(SUPPL 1):I45-I49. DOI:10.1136/NEURINTSURG-2013-010895.REP MEDTRONIC RECEIVED A LITERATURE ARTICLE PERTAINING TO A STUDY AIMED TO ASSESS PERFORMANCE OF THE SOLITAIRE FR DEVICE IN CONTRAST WITH THE RESULTS FROM THE SWIFT (SOLITAIRE WITH THE INTENTION FOR THROMBECTOMY) AND TREVO 2 (TREVO VERSUS MERCI RETRIEVERS FOR THROMBECTOMY REVASCULARIZATION OF LARGE VESSEL OCCLUSIONS IN ACUTE ISCHEMIC STROKE) TRIALS. 354 PATIENTS WERE INCLUDED IN THE STUDY. THE MEAN AGE OF THE PATIENTS WAS 67 YEARS OLD WITH A MAJORITY MALE. OUTCOMES INCLUDED SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) ON 24 H FOLLOW-UP HEAD CT, AND MORTALITY AT 90 DAYS. SICH WAS DEFINED AS ANY PARENCHYMAL HEMATOMA, SUBARACHNOID HEMORRHAGE, OR INTRAVENTRICULAR HEMORRHAGE ASSOCIATED WITH WORSENING OF THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE BY =4 WITHIN 24 H. MORTALITY OCCURRED IN 95 PATIENTS OF 315 TOTAL, SICH OCCURRED IN 35 PATIENTS OF 352. PER THE AUTHORS OF THE ARTICLE, SEVERAL FACTORS MAY EXPLAIN THE MORALITY RATE IN THIS COHORT, INCLUDING HETEROGENEITY BETWEEN THE GROUPS, HIGHER PROPORTION OF BASILAR OCCLUSION, LACK OF AGE AND NIHSS CUT OFFS, AND VARIABILITY IN THE ENDOVASCULAR SELECTION PROTOCOLS ACROSS PARTICIPATING CENTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956517 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death| O