BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 20548793 · Received October 28, 2024

    Report

    Report Number
    2029214-2024-02007
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    October 24, 2023
    Report Date
    October 28, 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: ZHU, D., WANG, C., MA, P., QI, D., CAO, W., LI, S., DU, M., HE, J., YE, S., SONG, T., HU, R., LI, P., ZHENG, T., LIU, J., & FANG, Y.. ARM-ONLY COMBINED TRANSARTERIAL AND TRANSVENOUS ACCESS FOR NEUROINTERVENTIONAL PROCEDURES: A DOUBLECENTER RETROSPECTIVE STUDY. THE BRITISH JOURNAL OF RADIOLOGY 96(1152), 20230465. 2023. DOI:10.1259/BJR.20230465 A.3. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 "ARM-ONLY COMBINED TRANSARTERIAL AND TRANSVENOUS ACCESS FOR NEUROINTERVENTIONAL PROCEDURES: A DOUBLE-CENTER RETROSPECTIVE STUDY". THE TIME FRAME OF THIS STUDY WAS FROM MARCH 2019 TO MAY 2023. THE STUDY POPULATION INCLUDED SIX MALES AND SEVEN FEMALES, WITH AGES RANGING FROM 15 TO 67 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: AXIUM COIL, ECHELON CATHETER, ONYX, APOLLO CATHETER, AND REACT-71 CATHETER. NO DEATHS WERE REPORTED IN THE STUDY. AMONG PATIENT ADVERSE EVENTS INCLUDED: -A PATIENT UNDERWENT INTRACRANIAL DURAL ARTERIOVENOUS FISTULA (DAVF) EMBOLIZATION. RIGHT RADIAL ARTERY APPROACHES USED 6F SHORT SHEATH AND THE RIGHT MEDIAN CUBITAL VEIN (MCV) APPROACH USED A 6F NEUROMAX LONG SHEATH. RIGHT EXTERNAL CAROTID ARTERY (ECA) ANGIOGRAM SHOWED A RIGHT SIGMOID SINUS DAVF. A CAT5 CATHETER WAS POSITIONED INTO THE RIGHT ECA THROUGH THE RIGHT RA ACCESS. THEN, AN ECHELON10 MICROCATHETER WAS SUPERSELECTED TO THE FISTULA, AND COILING WAS PERFORMED BY AXIUM 1.5/40. AFTERWARD, A NEUROMAX LONG SHEATH WAS POSITIONED INTO THE RIGHT INTERNAL JUGULAR VEIN. ANGIOGRAM INDICATED A SEVERE STENOSIS AT THE VENOUS END OF THE FISTULA. A 6F DA CATHETER WAS POSITIONED INTO THE RIGHT SIGMOID SINUS. ANGIOPLASTY WAS CONDUCTED USING A VIATRAC BALLOON, AND THE STENOSIS WAS SIGNIFICANTLY IMPROVED AFTERWARD. AN APOLLO MICROCATHETER WAS INDWELLED AT THE ARTERIAL END OF THE FISTULA, AND EMBOLIZATION WAS PERFORMED BY INJECTING 0.8 ML OF ONYX-18. POST-OPERATIVE VENOGRAPHY AND ANGIOGRAM DEMONSTRATED A TOTAL DAVF DISAPPEARANCE. UNOBSTRUCTED COMPRESSION WAS PERFORMED USING A TR BAND RADIAL COMPRESSION DEVICE FOR ARTERIAL ACCESS SITE CLOSURE WHILE MANUAL COMPRESSION WAS PERFORMED FOR RIGHT MCV APPROACH CLOSURE. IT WAS REPORTED THAT ALL PROCEDURES WERE UNEVENTFUL, ALLOWING PATIENTS TO AMBULATE ON THE SAME DAY. AT DISCHARGE, ALL PATIENTS EXHIBITED MODIFIED RANKIN SCORES OF 0¿2, WITHOUT ANY ACCESS SITE OR PERIOPERATIVE COMPLICATIONS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965426 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention