BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE AB STENT

    MDR report key: 20556016 · Received October 29, 2024

    Report

    Report Number
    2029214-2024-02004
    Event Type
    Death
    Date Received
    October 29, 2024
    Date of Event
    January 1, 2020
    Report Date
    October 29, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-SAB (UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: YUAN SHEN Y, LI M, WANG S, XIA L, NI X, ZHOU L, ZHONG J, SHI H, DONG Z. TREATMENT OF INTRACRANIAL ANEURYSMS WITH PIPELINE EMBOLIZATION DEVICE: A SINGLE-CENTER EXPERIENCE. WORLD NEUROSURGERY 186:E206-E212 2024. HTTPS://DOI.ORG/10.1016/J.WNEU .2024.03.1. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    LITERATURE WAS REVIEWED REGARDING COMPARISON OF THE EFFICACY AND SAFETY BETWEEN INTRAVENOUS THROMBOLYSIS, DIRECT ENDOVASCULAR THERAPY, AND BRIDGING THERAPY FOR ACUTE BASILAR ARTERY OCCLUSION IN CEREBRAL INFARCTION PATIENTS. THE TIME FRAME OF THIS STUDY WAS FROM JANUARY 2020 AND AUGUST 2023. MULTIPLE MANUFACTURERS¿ DEVICES WERE USED IN THE STUDY POPULATION. AMONG THE MEDTRONIC DEVICES, THE SOLITAIRE AB STENT WAS UTILIZED. VARIOUS ADVERSE EVENTS WERE DOCUMENTED, INCLUDING SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (SICH), WAS 8.7% (10/114), THE STROKE-ASSOCIATED PNEUMONIA RATE WAS 52.6% (60/114), AND THE MORTALITY RATE WAS 39.5% (45/114).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978890 SOLITAIRE AB STENT INTRACRANIAL NEUROVASCULAR STENT NJE MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-SAB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| D SEE H11...