BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 20263383 · Received September 19, 2024

    Report

    Report Number
    2029214-2024-01608
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    October 19, 2023
    Report Date
    November 1, 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-ECHELON (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: DUAN, Y., SHEN, J., QIN, X., XU, B., MAO, R., LI, J., AN, Q., LIAO, Y., ZHANG, F., <(>&<)> CHEN, G.. THE SAFETY AND EFFICACY OF LEO STENTS WITH COILING OR ALONE FOR ANTERIOR CEREBRAL ARTERY ANEURYSMS. CURRENT NEUROVASCULAR RESEARCH 20(5):560-567 2024. DOI:10.2174/0115672026271147231130111233 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE NONE OF THE EVENTS WERE RELATE DIRECTLY TO MEDTRONIC DEVICES/PRODUCTS.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: "THE SAFETY AND EFFICACY OF LEO STENTS WITH COILING OR ALONE FOR ANTERIOR CEREBRAL ARTERY ANEURYSMS" (PAGE 560). THE TIME FRAME OF THIS STUDY WAS: JANUARY 2016 TO OCTOBER 2021 (PAGE 560). THE FOLLOWING MEDTRONIC DEVICES WERE USED: ECHELON 10 MICROCATHETER (PAGE 561). DEATHS OCCURRED IN THE STUDY POPULATION: NO DEATHS WERE REPORTED IN THE STUDY. AMONG PATIENT ADVERSE EVENTS INCLUDED: SYMPTOMATIC ISCHEMIC INFARCT: TWO CASES (3.5%) WERE RECORDED AS HAVING MILD SYMPTOMATIC CEREBRAL INFARCTION, WHICH SHOWED AS DYSPHASIA THAT RECOVERED IN THREE MONTHS (PAGES 562-563). INTRA-PARENT ARTERY NARROWING: EIGHT PATIENTS SHOWED THIS COMPLICATION DURING FOLLOW-UP (PAGE 563). INJURED SIDE BRANCHES: FOUR PATIENTS (12.3%) EXPERIENCED THIS COMPLICATION (PAGE 562). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335901 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other SEE H11.