BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR2

    MDR report key: 6927885 · Received October 8, 2017

    Report

    Report Number
    2029214-2017-01124
    Event Type
    Injury
    Date Received
    October 8, 2017
    Date of Event
    July 9, 2017
    Report Date
    September 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K123378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEE, D. H., SUNG, J. H., KIM, S. U., YI, H. J., HONG, J. T., <(>&<)> LEE, S. W. (2017). EFFECTIVE USE OF BALLOON GUIDE CATHETERS IN REDUCING INCIDENCE OF MECHANICAL THROMBECTOMY RELATED DISTAL EMBOLIZATION. ACTA NEUROCHIRURGICA, 159(9), 1671-1677. DOI:10.1007/S00701-017-3256-3 THE SOLITAIRE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENT OCCURRED IN THE PATIENT AFTER USE OF THE SOLITAIRE DEVICE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF DISTAL EMBOLIZATION AFTER SOLITAIRE THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE USE OF BALLOON GUIDE CATHETER TO EFFECTIVELY ACHIEVE FLOW ARREST AND THROMBUS ASPIRATION DURING INTERVENTION TO AVOID DISTAL EMBOLIZATION. THE AUTHORS RETROSPECTIVELY REVIEWED 139 PATIENTS WHO EXPERIENCED OCCLUSIONS IN THE MIDDLE CEREBRAL ARTERY (MCA) OR INTERNAL CAROTID ARTERY (ICA) AND UNDERWENT MECHANICAL THROMBECTOMY WITH OR WITHOUT A BALLOON GUIDE CATHETER. THE BALLOON GUIDE CATHETER GROUP CONSISTED OF 73 PATIENTS; THE AVERAGE AGE WAS 66.8 YEARS; 30 PATIENTS WERE FEMALE. THE NON-BALLOON GUIDE CATHETER GROUP CONSISTED OF 66 PATIENTS; THE AVERAGE AGE WAS 64.6 YEARS; 29 PATIENTS WERE FEMALE. THE ARTICLE STATES THAT ONE PATIENT PRESENTED WITH LEFT-SIDED HEMIPARESIS. DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED A PROXIMAL M1 OCCLUSION. MECHANICAL THROMBECTOMY WAS PERFORMED WITH A SOLITAIRE FR 4X20 STENT. THE ARTICLE STATES THAT THE STENT WAS POSITIONED AT THE OCCLUDED SITE FOR FIVE MINUTES, THEN RETRIEVED. AFTER RETRIEVAL, THE PROXIMAL M1 WAS RECANALIZED, HOWEVER THE DISTAL M2 WAS OCCLUDED BY DISTAL EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707449 SOLITAIRE FR2 CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE) SFR2-4-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other