BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE FR

    MDR report key: 7222528 · Received January 26, 2018

    Report

    Report Number
    2029214-2018-00057
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    November 4, 2017
    Report Date
    January 26, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    NRY
    PMA / PMN Number
    K113455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KANNATH, S. K., RAJAN, J. E., SYLAJA, P., SARMA, P. S., SUKUMARAN, S., SREEDHARAN, S. E., & KAPILAMOORTHY, T. R. (2018). DWELL TIME OF STENTRIEVER INFLUENCES COMPLETE REVASCULARIZATION AND FIRST-PASS TICI 3 REVASCULARIZATION IN ACUTE LARGE VESSEL OCCLUSIVE STROKE. WORLD NEUROSURGERY, 110, 169-173. HTTPS://DOI.ORG/10.1016/J.WNEU.2017.10.155. THE SOLITAIRE FR STENTS HAVE NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (SICH) IS A KNOWN COMPLICATION OF MECHANICAL THROMBECTOMY TREATMENT OF PATIENTS WITH ACUTE ISCHEMIC STROKE. BASED ON THE REPORTED INFORMATION, THERE DOES NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THE EVENTS OCCURRED IN THE PATIENTS POST-PROCEDURE AND ITS CAUSE COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC LITERATURE REVIEW FOUND REPORTS INTRAPARENCHYMAL HEMORRHAGE AFTER SOLITAIRE FR MECHANICAL THROMBECTOMY. THE PURPOSE OF THIS ARTICLE WAS TO ANALYZE THE EFFECT OF DIFFERENT STENT DEPLOYMENT DWELL TIME (DT) ON FINAL ANGIOGRAPHIC AND CLINICAL OUTCOMES OF PATIENTS WHO UNDERWENT MECHANICAL THROMBECTOMY OF LARGE VESSEL OCCLUSION IN ACUTE ISCHEMIC STROKE. THE AUTHORS RETROSPECTIVELY 40 PATIENTS (MEAN AGE 56.85 YEARS, 65% MALE) WHO PRESENTED TO THEIR STROKE CENTER WITH ACUTE ISCHEMIC STROKE. ALL PATIENTS UNDERWENT MECHANICAL THROMBECTOMY USING A SOLITAIRE FR STENT. THE ARTICLE STATES THAT SYMPTOMATIC INTRAPARENCHYMAL HEMORRHAGE (PARENCHYMAL HEMATOMA TYPE 2) WAS OBSERVED IN 4 OF THE 40 PATIENTS P OST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66298 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other