BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 24809175 · Received April 7, 2026

    Report

    Report Number
    2029214-2026-00625
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    January 9, 2024
    Report Date
    April 7, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FUGA, M., ISHIBASHI, T., AOKI, K., TACHI, R., IRIE, K., KATO, N., KAN, I., HATAOKA, S., NAGAYAMA, G., SANO, T., TANAKA, T., MURAYAMA, Y.. INTERMEDIATE CATHETER USE IS ASSOCIATED WITH COMPLETE OCCLUSION AND DENSE PACKING IN COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS: A PROPENSITY SCORE MATCHED STUDY. JOURNAL OF NEUROINTERVENTIONAL SURGERY 2024. DOI: 10.1136/JNIS-2023-021258 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 INTERMEDIATE CATHETER USE IS ASSOCIATED WITH COMPLETE OCCLUSION AND DENSE PACKING IN COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS: A PROPENSITY SCORE MATCHED STUDY. MULTIPLE MANUFACTURER'S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: NAVIEN INTERMEDIATE CATHETER. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: NINETEEN PATIENTS EXPERIENCED ISCHEMIC COMPLICATIONS, NINE OF WHICH WERE SYMPTOMATIC (SYMPTOMATIC COMPLICATIONS WERE CLASSIFIED AS AN INCREASE OF AT LEAST ONE POINT IN THE MODIFIED RANKIN SCALE SCORE COMPARED WITH THE PREOPERATIVE LEVEL.) EIGHT PATIENTS EXPERIENCED HEMORRHAGIC COMPLICATIONS, THREE OF WHICH WERE SYMPTOMATIC (SYMPTOMATIC COMPLICATIONS WERE CLASSIFIED AS AN INCREASE OF AT LEAST ONE POINT IN THE MODIFIED RANKIN SCALE SCORE COMPARED WITH THE PREOPERATIVE LEVEL.) THREE PATIENTS EXPERIENCED INTERMEDIATE CATHETER (IMC) RELATED PARENT ARTERY DISSECTION. THREE PATIENTS UNDERWENT RETREATMENT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522297 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention