BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 24486384 · Received March 2, 2026

    Report

    Report Number
    2029214-2026-00331
    Event Type
    Death
    Date Received
    March 2, 2026
    Date of Event
    November 5, 2024
    Report Date
    March 2, 2026
    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

    A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ONLINE PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. G.4. PMA CODE MISSING AS DEVICE MODEL AND LOT IS UNKNOWN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ZHAO, B., WANG, C., LIANG, W., ZHAO, Z., MANG, J. (2025). ECONOMIC AND EFFICIENT: INTRODUCING THE BIFURCATION-INVISIBLE SIGN IN ENDOVASCULAR THROMBECTOMY FOR MIDDLE CEREBRAL ARTERY OCCLUSIONS. CEREBROVASCULAR DISEASES (BASEL, SWITZERLAND), 54(5), 664¿673. HTTPS://DOI.ORG/10.1159/000542388 LITERATURE WAS REVIEWED REGARDING THE USE OF THE BIFURCATION-INVISIBLE (BI) ANGIOGRAPHIC SIGN TO GUIDE FIRST-LINE THROMBECTOMY STRATEGY IN PATIENTS WITH ACUTE LARGE-VESSEL OCCLUSION STROKE. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: SOLITAIRE FR AND SOLITAIRE AB STENT RETRIEVERS; NAVIEN INTERMEDIATE CATHETER; REACT 68 AND REACT 71 ASPIRATION CATHETERS. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE CAUSES OF DEATH WERE NOT NOTED BUT THERE WERE 67 DEATHS IN THE ENTIRE PATIENT POPULATION. AMONG ALL MEDTRONIC DEVICE PATIENTS, ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: SYMPTOMATIC INTRACEREBRAL HEMORRHAGE, POOR FUNCTIONAL OUTCOMES (PATIENTS THAT DID NOT HAVE A 90-DAY MODIFIED RANKIN SCALE SCORES 0¿2). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2629 SOLITAIRE FR CATHETER, THROMBUS RETRIEVER NRY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SFR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death