BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 24758298 · Received April 1, 2026

    Report

    Report Number
    2029214-2026-00592
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    June 3, 2025
    Report Date
    April 1, 2026
    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

    SOURCE LINK/CITATION: ZHANG, F.-F., THAPA, M., ZOU, H.-Y., YAO, J.-B., CHEN, P.-B., WU, P., JI, Z.-Y., XU, S.-C., WANG, X., SHI, H.-Z., WANG, C.-L. (2025). OPTICAL COHERENCE TOMOGRAPHY EVALUATION OF VESSEL WALL MICROSTRUCTURE BEFORE AND AFTER ENDOVASCULAR STENT TREATMENT FOR INTRACRANIAL VERTEBROBASILAR ATHEROSCLEROTIC STENOSIS. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 15(6), 5520¿5533. HTTPS://DOI.ORG/10.21037/QIMS-2024-2487 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ONLINE PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. G.4. PMA CODE MISSING AS DEVICE MODEL AND LOT IS UNKNOWN. 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

    ZHANG, F.-F., THAPA, M., ZOU, H.-Y., YAO, J.-B., CHEN, P.-B., WU, P., JI, Z.-Y., XU, S.-C., WANG, X., SHI, H.-Z., WANG, C.-L. (2025). OPTICAL COHERENCE TOMOGRAPHY EVALUATION OF VESSEL WALL MICROSTRUCTURE BEFORE AND AFTER ENDOVASCULAR STENT TREATMENT FOR INTRACRANIAL VERTEBROBASILAR ATHEROSCLEROTIC STENOSIS. QUANTITATIVE IMAGING IN MEDICINE AND SURGERY, 15(6), 5520¿5533. HTTPS://DOI.ORG /10.21037/QIMS-2024-2487 LITERATURE WAS REVIEWED REGARDING THE USE OF OPTICAL COHERENCE TOMOGRAPHY TO EVALUATE INTRACRANIAL VERTEBROBASILAR ARTERY STENOSIS B EFORE AND AFTER ENDOVASCULAR STENT TREATMENT. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: 6 F OR 8 F NAVIEN GUIDE CATHETER AND ECHELON-10 MICROCATHETER. NO DEATH OCCURRED IN THE STUDY POPULATION. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PLAQUE PROLAPSE (N = 6), THROMBUS PROLAPSE (WHITE THROMBUS) (N = 6), STENT THROMBOSIS (WHITE THROMBUS) (N = 2), VESSEL DISSECTION (N = 1), 1 PATIENT WITH BILATERAL LEFT GAZE, DIZZINESS, AND MULTIPLE PUNCTATE INFARCTS BELIEVED TO HAVE BEEN CAUSED BY PLAQUE DETACHMENT AND EMBOLIZATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818177 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-ECHELON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention