BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX CATHETER

    MDR report key: 21610610 · Received March 14, 2025

    Report

    Report Number
    2029214-2025-00682
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    September 27, 2023
    Report Date
    March 14, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-NV-ECHELON; G2: CITATION: AUTHORS: DAN, B., ZHU, B., ZENG, W., PENG, T., LIU, J., LI, X., ZHANG, J. CLINICAL STUDY OF SYMPTOMATIC NONACUTE INTRACRANIAL LARGE ARTERIAL OCCLUSION WITH ENDOVASCULAR RECANALIZATION. JOURNAL OF NEUROLOGICAL SURGERY. PART B. SKULL BASE 85(5):481-488 2024. DOI:10.1055/S-0043-1774791. 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: "CLINICAL STUDY OF SYMPTOMATIC NONACUTE INTRACRANIAL LARGE ARTERIAL OCCLUSION WITH ENDOVASCULAR RECANALIZATION." THE OBJECTIVE IS TO EVALUATE THE SAFETY, FEASIBILITY, AND CLINICAL EFFECT OF SIMPLE BALLOON DILATATION AND STENT IMPLANTATION FOR SYMPTOMATIC NONACUTE OCCLUSION OF THE INTRACRANIAL LARGE ARTERY (NA-ILAO). THE TIME FRAME OF THIS STUDY WAS: JANUARY 2015 TO OCTOBER 2020. (PAGE 482) MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. DEVICES FROM STRYKER, CODMAN SHURTLEFF, AND OTHERS WERE UTILIZED. (PAGE 482) THE FOLLOWING MEDTRONIC DEVICES WERE USED: NAVIEN SUPPORT CATHETERS AND ECHELON 10 MICROCATHETERS WERE USED IN THE PROCEDURES. DEATHS: THERE WERE NO DEATHS REPORTED WITHIN 30 DAYS. AMONG PATIENT ADVERSE EVENTS INCLUDED: PERIOPERATIVE COMPLICATIONS: 2 IN THE BALLOON DILATATION GROUP (ONE CASE OF DISSECTION AND ONE CASE OF ASYMPTOMATIC CEREBRAL HEMORRHAGE) AND 3 IN THE STENT GROUP (ONE CASE OF SYMPTOMATIC CEREBRAL HEMORRHAGE, ONE CASE OF ACUTE INTRASTENT THROMBOSIS, AND ONE CASE OF BRANCH EMBOLIZATION). (PAGE 484), STROKE WITHIN 30 DAYS: 0 IN THE BALLOON DILATATION GROUP AND 3 IN THE STENT GROUP. (PAGE 484), RESTENOSIS: 2 CASES IN THE BALLOON DILATATION GROUP AND 1 IN THE STENT GROUP. (PAGE 484), RE-OCCLUSION: 0 IN THE BALLOON DILATATION GROUP AND 2 IN THE STENT GROUP. (PAGE 484), STROKE RECURRENCE (BEYOND 30 DAYS): 1 CASE IN THE BALLOON DILATATION GROUP AND 2 CASES IN THE STENT GROUP. (PAGE 484), CLINICAL OUTCOMES: 90-DAY GOOD CLINICAL OUTCOME (MRS = 2) WAS 21 (87.5%) IN THE BALLOON DILATATION GROUP AND 10 (83.3%) IN THE STENT GROUP. (PAGE 484) NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640952 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other SEE H11.