BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 13488772 · Received February 8, 2022

    Report

    Report Number
    2029214-2022-00186
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    October 30, 2020
    Report Date
    February 8, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OZAKI T, NICHOLSON P, SCHAAFSMA JD, ET AL. ENDOVASCULAR THERAPY OF ACUTE ISCHEMIC STROKE IN PATIENTS WITH LARGE-VESSEL OCCLUSION ASSOCIATED WITH ACTIVE MALIGNANCY. JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES. 2021;30(2). DOI:10.1016/J.JSTROKECEREBROVASDIS.2020.105455. SEE MANUFACTURER REPORT # 2029214-2022-00183, 2029214-2022-00184, AND 2029214-2022-00185 FOR OTHER EVENTS FROM THIS ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    OZAKI T, NICHOLSON P, SCHAAFSMA JD, ET AL. ENDOVASCULAR THERAPY OF ACUTE ISCHEMIC STROKE IN PATIENTS WITH LARGE-VESSEL OCCLUSION ASSOCIATED WITH ACTIVE MALIGNANCY. JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES. 2021;30(2). DOI:10.1016/J.JSTROKECEREBROVASDIS.2020.105455. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH SOLITAIRE STENT RETRIEVERS AND NAVIEN CATHETERS. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE OUTCOME OF ENDOVASCULAR THERAPY (EVT) FOR ACUTE ISCHEMIC STROKE FOR PATIENTS WITH ACTIVE MALIGNANCY COMPARED TO THOSE WITHOUT MALIGNANCY. PATIENTS WERE DIVIDED INTO TWO GROUPS, THOSE WITH ACTIVE MALIGNANCY (ONCOLOGY GROUP - OG) AND THOSE WITHOUT (NON-ONCOLOGY GROUP, NOG). 300 PATIENTS WERE INCLUDED IN THIS STUDY. THERE WERE 19 EVT PROCEDURES (18 PATIENTS) IN THE OG AND 285 PROCEDURES (282 PATIENTS) IN THE NOG. THE MEAN AGE OF THE OG GROUP WAS 68, AND 5 OF THE EVT PROCEDURES WERE MALE. THE MEAN AGE OF THE NOG GROUP WAS 71, AND 125 OF THE EVT PROCEDURES WERE MALE. EVT CASES INCLUDED STENT-RETRIEVER TECHNIQUE, DIRECT ASPIRATION FIRST PASS TECHNIQUE, AND A COMBINED TECHNIQUE. IT IS UNCLEAR HOW MANY OF THESE PROCEDURES INVOLVED SOLITAIRE AND NAVIEN DEVICES. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE AND NAVIEN DEVICES. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -SYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) WITHIN 24 HOURS AFTER EVT FOR THE OG WAS 0 CASES AND 19 CASES (6.3%) IN THE NOG. -CLOT FRAGMENTATION RATE FOR THE OG WAS 7 CASES (36.8%) VERSUS 137 CASES (50.1%) IN THE NOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904691 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other