BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 20305801 · Received September 25, 2024

    Report

    Report Number
    2029214-2024-01641
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    March 22, 2023
    Report Date
    September 25, 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

    G2: CITATION: AUTHORS: LIU C, GUO K, WU X, WU L, CAI Y, HU X, FANG B. UTILITY OF LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS¿) STENT FOR TREATMENT OF ACUTELY RUPTURED BIFURCATION ANEURYSMS: A SINGLE-CENTER STUDY. FRONTIERS IN NEUROLOGY 14:1050369 2023. DOI:10.3389/FNEUR.2023.1050369 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

    MEDTRONIC LITERATURE REVIEW FOUND REPORTED OF INTRAOPERATIVE THROMBOSIS, HEMORRHAGE, AND RESIDUAL NECK ANEURYSM IN ASSOCIATION WITH STENT ASSISTED COIL EMBOLIZATION USING THE ECHELON MICROCATHETER. THE TIME LINE FOR THIS STUDY WAS BETWEEN JANUARY 2017 AND DECEMBER 2021. THE PURPOSE OF THIS ARTICLE WAS TO ASSESS THE EFFECTIVENESS IN TREATING RUPTURED ANEURYSMS AT THE BIFURCATION USING THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT STENT (LVIS) ASSISTED COIL EMBOLIZATION. THE AUTHORS REVIEWED 41 CASES OF PATIENTS TREATED FOR ACUTE RUPTURED INTRACRANIAL ANEURYSMS ARISING AT THE BIFURCATION USING LVIS ASSISTED COILING WITH THE ECHELON MICROCATHETER. OF THE 41 PATIENTS, THE AVERAGE AGE WAS 52 YEARS, 24 WERE FEMALE AND 17 WERE MALE. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ECHELON MICROCATHETER. IN ADDITION, AT DISCHARGE 35 PATIENTS ACHIEVED A MRS SCORE WITHIN 0-2, FOUR PATIENTS ACHIEVED A SCORE OF 3 AND TWO PATIENTS SCORED 4. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: INTRAOPERATIVE THROMBOSIS OCCURRED IN 2 PATIENTS RESOLVED WITH INTRA-ARTERIAL TIROFIBAN INFUSION INTRAOPERATIVE HEMORRHAGE OCCURRED IN 1 PATIENT MANAGED WITH NEUTRALIZING HEPARIN, COIL EMBOLIZATION RESIDUAL NECK IN 6 PATIENTS 18 PATIENTS REQUIRED LUMBAR DRAINS 12 PATIENTS REQUIRED LUMBAR PUNCTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244147 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O