BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN SOLITAIRE

    MDR report key: 18387655 · Received December 22, 2023

    Report

    Report Number
    2029214-2023-02452
    Event Type
    Death
    Date Received
    December 22, 2023
    Date of Event
    January 6, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE ATTACHMENTS FOR LITERATURE ARTICLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HONGXING FAN, ZHENHUI LI, YI LI, YANPING TAN, ZHENLIN MAO, QIAN LIU, AND YOUFENG ZHU; FRONTIERS IN NEUROLOGY; 2023; 14:1138993; COMPARISON OF A DIRECT ASPIRATION FIRST PASS TECHNIQUE VS. STENT RETRIEVER THROMBECTOMY FOR THE TREATMENT OF ACUTE LARGE VESSEL OCCLUSION STROKE IN THE ANTERIOR CIRCULATION WITH ATRIAL FIBRILLATION; DOI: 10.3389/FNEUR.2023.1138993 MEDTORNIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATEINTS TREATED WITH SOLITAIRE FR STENTS HAD COMPLICATIONS. THE STENT RETRIEVER THROMBECTOMY (SRT) AND A DIRECT ASPIRATION FIRST-PASS TECHNIQUE (ADAPT) ARE THE TWO MAIN MECHANICAL THROMBECTOMY (MT) TECHNIQUES FOR ACUTE ISCHEMIC STROKE. THE PURPOSE OF THE STUDY WAS TO COMPARE THE EFFICACY AND SAFETY OF BOTH TECHNIQUES FOR THE TREATMENT OF ACUTE LARGE VESSEL OCCLUSION STROKE IN THE ANTERIOR CIRCULATION WITH ATRIAL FIBRILLATION. THE STUDY INCLUDED PATIENTS TREATED AT THE STUDY INSTITUTION FROM JANUARY 2018 TO JUNE 2022 WHO RECEIVED MECHANICAL THROMBECTOMY BY EITHER SRT OR ADAPT. IN THIS STUDY, AFTER SCREENING 431 PATIENTS, 92 ELIGIBLE PATIENTS, WITH 48 PATIENTS RECEIVED SRT AND 44 PATIENTS RECEIVED ADAPT. PATIENTS RECEIVED ADAPT USING AXS CATALYST-6 AS FRONT-LINE THERAPY. ALL STENT RETRIEVER PROCEDURES WERE PERFORMED USING THE SOLITAIRE FR.  THE CHOICE OF STR OR ADAPT WAS LEFT TO THE DISCRETION OF THE OPERATOR, USUALLY BASED ON THE ANATOMICAL LOCATION OF THE THROMBUS OBSTRUCTION, PREOPERATIVE JUDGMENT OF THE ETIOLOGY AND PATHOGENESIS, AND THE SIZE OF THE THROMBUS. SRT PROCEDURE: ALL PATIENTS WERE TREATED WITH LOCAL ANESTHESIA, PREFERABLY THROUGH THE RIGHT FEMORAL ARTERY, TO ESTABLISH ACCESS. A BALLOON GUIDE CATHETER (BGC) WAS NOT USED IN ALL PROCEDURES DUE TO LIMITATIONS IN AVAILABLE DEVICE CONDITIONS. THE OPERATOR COULD CHOOSE ANY NECESSARY THROMBECTOMY DEVICE AND METHOD TO OBTAIN AN ACCEPTABLE THERAPEUTIC EFFECT IF A SUCCESSFUL RECANALIZATION COULD NOT BE ACCOMPLISHED AFTER THREE ATTEMPTS USING SRT OR ADAPT. THE PRIMARY OUTCOME IS RECANALIZATION RATE. THE SECONDARY OUTCOMES ARE IMPROVEMENT OF NIHSS SCORE AT 24 H AFTER PROCEDURE AND DISCHARGE, 90-DAY FAVORABLE CLINICAL PROGNOSIS, SYMPTOMATIC INTRACRANIAL HEMORRHAGE AND 90-DAY ALL-CAUSE MORTALITY. RESULTS: OF THE 48 PATIENTS TREATED WITH SRT, 16 HAD FIRST PASS SUCCESS, 42 HAD FINAL ETICI 2C/3, 11 HAD DISTAL EMBOLIZATION, 5 HAS SYMPTOMATIC INTRACRANIAL HEMORRHAGE, 27 HAD IMPROVEMENT OF NHISS SCORE OF 4 OR HIGHER AT DISCHARGE, AND 9 HAD 90 DAY MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291247 UNKNOWN SOLITAIRE CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SOLITAIRE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Death