BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 24820829 · Received April 8, 2026

    Report

    Report Number
    2029214-2026-00635
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    April 19, 2025
    Report Date
    April 8, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SOURCE CITATION/LINK: HAN, H. J., PARK, K. Y., KIM, B. M., KIM, Y. B., JEON, H.-J., SUH, S. H., SUH, S., KIM, J.-J., KIM, J.-H., JANG, C. K., KIM, D. J., LEE, J. K., KIM, S., CHUNG, K. S., KIM, S., YOON, S., & KIM, M. J. (2025). FLOWISE FLOW DIVERTER FOR TREATMENT OF UNRUPTURED WIDE-NECK INTRACRANIAL ANEURYSMS: A PROSPECTIVE, MULTICENTER, SINGLE-ARM, OPEN-LABEL, PIVOTAL STUDY. KOREAN JOURNAL OF RADIOLOGY, 26(7), 716¿726. HTTPS://DOI.ORG/10.3348/KJR.2024.1212 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 ACCEPTANCE 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

    HAN, H. J., PARK, K. Y., KIM, B. M., KIM, Y. B., JEON, H.-J., SUH, S. H., SUH, S., KIM, J.-J., KIM, J.-H., JANG, C. K., KIM, D. J., LEE, J. K., KIM, S., CHUNG, K. S., KIM, S., YOON, S., & KIM, M. J. (2025). FLOWISE FLOW DIVERTER FOR TREATMENT OF UNRUPTURED WIDE-NECK INTRACRANIAL ANEURYSMS: A PROSPECTIVE, MULTICENTER, SINGLE-ARM, OPEN-LABEL, PIVOTAL STUDY. KOREAN JOURNAL OF RADIOLOGY, 26(7), 716¿726. HTTPS://DOI.ORG/10.3348/KJR.2024.1212. LITERATURE WAS REVIEWED REGARDING THE USE OF THE FLOWISE FLOW DIVERTER FOR THE TREATMENT OF UNRUPTURED WIDE-NECK INTRACRANIAL ANEURYSMS. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE ONLY MEDTRONIC DEVICE USED IN THE STUDY WAS THE NAVIEN INTERMEDIATE CATHETER. NO DEATHS OCCURRED IN THE STUDY POPULATION. AMONG PATIENTS IN WHOM A MEDTRONIC DEVICE WAS USED, ADVERSE EVENTS / DEVICE-RELATED PERFORMANCE ISSUES INCLUDED IN-STENT THROMBOSIS, INTERNAL CAROTID ARTERY RUPTURE DURING BALLOON ANGIOPLASTY WITH RESULTANT SEVERE NEUROLOGIC DEFICIT, VISUAL FIELD DEFECT, VISUAL IMPAIRMENT, PUNCTURE SITE HEMATOMA, HEADACHE, NAUSEA, SKIN RASH, PARENT ARTERY STENOSIS GREATER THAN 50% AT FOLLOW-UP, AND INCOMPLETE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312844 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability| R