BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON

    MDR report key: 23064316 · Received September 16, 2025

    Report

    Report Number
    2029214-2025-02031
    Event Type
    Death
    Date Received
    September 16, 2025
    Date of Event
    April 11, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-ECHELON (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: ZHANG, X., LI, Y., YIN, K., HAO, Z., FU, Y., YANG, Q., XU, G., & LV, P. ENDOVASCULAR RECANALIZATION OF SYMPTOMATIC CHRONIC CEREBRAL ARTERY OCCLUSION: PREDICTORS FOR SUCCESSFUL RECANALIZATION AND PERIOPERATIVE COMPLICATIONS. FRONTIERS IN NEUROLOGY 16:1453841 2025. DOI:10.3389/FNEUR.2025.1453841 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 A REPORT OF RECANALIZATION HEMORRHAGE LEADING TO DEATH, OPHTHALMIC ARTERY OCCLUSION, SUBARACHNOID HEMORRHAGE, INTRAPARENCHYMAL HEMORRHAGE, DISTAL EMBOLIZATION ACCOMPANIED BY LIMB HEMIPLEGIA, AND RE-OCCLUSION OF IN-STENT THROMBOSIS WITH PROGRESSION OF HEMIPLEGIA IN ASSOCIATION WITH ENDOVASCULAR RECANALIZATION UTILIZING THE ECHELON CATHETER. THE STUDY WAS PERFORMED BETWEEN FEBRUARY 2021 AND OCTOBER 2024. THE PURPOSE OF THIS ARTICLE WAS TO IDENTIFY POTENTIAL PREDICTORS FOR SUCCESSFUL RECANALIZATION. THE AUTHORS REVIEWED 103 CASES OF PATIENTS TREATED FOR CHRONIC CEREBRAL ARTERY OCCLUSIONS USING ENDOVASCULAR RECANALIZATION WITH AN ECHELON CATHETER. OF THE 103 PATIENTS, THE AGE RANGE WAS 32-81 YEARS, 25 WERE FEMALE AND 78 WERE MALE. THE RESPONSIBLE ARTERIES OF THE SELECTED PATIENTS INCLUDE COMPLETE OCCLUSION OF THE INTERNAL CAROTID ARTERY (BOTH THE INTRACRANIAL AND EXTRACRANIAL SEGMENTS), THE MIDDLE CEREBRAL ARTERY, THE VERTEBRAL ARTERY (BOTH THE INTRACRANIAL AND EXTRACRANIAL SEGMENTS) AND THE BASILAR ARTERY. THE OVERALL TECHNICAL SUCCESS RATE WAS 68.9%. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE ECHELON CATHETER. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: MASSIVE RECANALIZATION HEMORRHAGE POSTOPERATIVELY RESULTING IN DEATH IN 1 PATIENT OPHTHALMIC ARTERY OCCLUSION IN 1 PATIENT SUBARACHNOID HEMORRHAGE IN 2 PATIENTS FOLLOWED BY MICROWIRE PERFORATION INTRAPARENCHYMAL HEMORRHAGE IN 1 PATIENT DISTAL EMBOLIZATION ACCOMPANIED BY MILD SYMPTOMS OF LIMB HEMIPLEGIA RE-OCCLUSION OF IN-STENT THROMBOSIS WITH PROGRESSION OF HEMIPLEGIA IN LIMBS IN 4 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2674157 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SEE H11.