BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 20330613 · Received September 29, 2024

    Report

    Report Number
    2029214-2024-01706
    Event Type
    Injury
    Date Received
    September 29, 2024
    Date of Event
    October 25, 2022
    Report Date
    September 29, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    GUANG-DONG LU, LIN-BO ZHAO, ZHEN-YU JIA, SHENG LIU; JOURNAL OF NEUROINTERVENTIONAL SURGERY; 2023; 15:1229¿1233; MICRO-GUIDEWIRE ELEC TROCOAGULATION FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS THAT ARE INACCESSIBLE BY MICROCATHETERIZATION: A CASE SERIES AND REVIEW OF THE LITERATURE; DOI:10.1136/JNIS-2022-019355 LITERATURE WAS REVIEWED REGARDING 'MICRO-GUIDEWIRE ELECTROCOAGULATION FOR THE TREATMENT OF INTRACRANIAL ANEURYSMS THAT ARE INACCESSIBLE BY MICROCATHETERIZATION: A CASE SERIES AND REVIEW OF THE LITERATURE'. THE TIME FRAME OF THIS STUDY WAS 'JANUARY 2020 TO MAY 2022'. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: 'SOLITAIRE STENT DETACHMENT SYSTEM, ECHELON-10 CATHETER'. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENT ADVERSE EVENTS INCLUDED: AN ATTEMPT TO CATHETERIZE AN ANEURYSM WITH AN ECHELON 10 MICROCATHETER BUT FAILED. A LACUNAR INFARCTION OF THE BRAINSTEM WITHOUT NEUROLOGICAL DEFICITS, A NEW INFARCTION IN THE RIGHT BASAL GANGLIA AREA. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053835 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention