BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 12679004 · Received October 22, 2021

    Report

    Report Number
    2029214-2021-01324
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    March 8, 2019
    Report Date
    October 22, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SEE MANUFACTURER REPORT # 2029214-2021-01323 FOR ANOTHER REPORT FROM THIS LITERATURE ARTICLE. KIM B, KIM BM, BANG OY, ET AL. CAROTID ARTERY STENTING AND INTRACRANIAL THROMBECTOMY FOR TANDEM CERVICAL AND INTRACRANIAL ARTERY OCCLUSIONS. NEUROSURGERY. 2020;86(2):213-220. DOI:10.1093/NEUROS/NYZ026. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    KIM B, KIM BM, BANG OY, ET AL. CAROTID ARTERY STENTING AND INTRACRANIAL THROMBECTOMY FOR TANDEM CERVICAL AND INTRACRANIAL ARTERY OCCLUSIONS. NEUROSURGERY. 2020;86(2):213-220. DOI:10.1093/NEUROS/NYZ026 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH A SOLITAIRE DEVICE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE EFFICACY AND SAFETY OF CAROTID ARTERY STENTING (CAS) IN COMBINATION WITH ENDOVASCULAR THROMBECTOMY (CAS-EVT) IN CERVICAL INTERNAL CAROTID ARTERY OCCLUSION (CICAO) - LARGE VESSEL OCCLUSION (LVO) PATIENTS AND TO COMPARE ITS OUTCOMES WITH THOSE OF EVT WITHOUT CAS (EVT-ALONE). OF THE 955 PATIENTS WHO UNDERWENT EVT, 75 PATIENTS (7.9%) HAD CICAO-LVO. FIFTY-SIX PATIENTS UNDERWENT CAS-EVT (74.6%), AND THE REMAINING 19 PATIENTS UNDERWENT EVT-ALONE (25.4%). THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -THERE WERE 70 INSTANCES OF SYMPTOMATIC INTRACRANIAL HEMORRHAGE (52 LVO ALONE, 9 TANDEM CICAO-LVO), 3 EVT ALONE, 6 CAS-EVT). -THERE WERE 8 INSTANCES OF RE-OCCLUSION OCCURRED DURING THE PROCEDURE (3 EVT ALONE, 5 CAS-EVT). HIGH RATES OF RE-OCCLUSION (66%) AND RESIDUAL STENOSIS OF THE CICA HAVE BEEN OBSERVED IN PATIENTS WHO UNDERWENT ANGIOPLASTY WITH DEFENSIVE STENT PLACEMENT FOR ACUTE TANDEM OCCLUSIONS. -THERE WERE 10 CASES (17.8%) OF IN-STENT THROMBOSIS REQUIRING GLYCOPROTEIN IIB/IIIA INHIBITOR INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583132 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention