BEUDAMED
    FDA Adverse Event Death Summary report: N

    REFLEX CATHETER

    MDR report key: 24719021 · Received March 30, 2026

    Report

    Report Number
    2029214-2026-00548
    Event Type
    Death
    Date Received
    March 30, 2026
    Date of Event
    September 4, 2024
    Report Date
    March 27, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID UNK-NV-RFX (UNKNOWN); IMPLANT DATE N/A; EXPLANT DATE N/A CITATION: YU, K.-W., LING, K., WU, C.-H., LIN, T.-M., TAI, W.-A., YANG, C.-H., KANG, Y.-M., LUO, C.-B., & CHANG, F.-C.. ENDOVASCULAR MANAGEMENT OF INTRACRANIAL CAROTID BLOWOUT SYNDROME IN PATIENTS WITH HEAD AND NECK CANCER. JOURNAL OF NEUROINTERVENTIONAL SURGERY 17(10):1127-1132 2025. DOI:10.1136/JNIS-2024-022221 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 ENDOVASCULAR MANAGEMENT OF INTRACRANIAL CAROTID BLOWOUT SYNDROME (ICBS) IN PATIENTS WITH HEAD AND NECK CANCER, COMPARING BALLOON EXPANDABLE CORONARY STENT GRAFTS (BES) VERSUS PARENT ARTERY OCCLUSION (PAO). THE TIME FRAME OF THIS STUDY WAS JANUARY 2018 TO JANUARY 2024. MULTIPLE MANUFACTURER¿S DEVICES WERE USED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: NAVIEN 072 INTERMEDIATE CATHETER WAS USED IN THE BALLOON-EXPANDABLE CORONARY STENT-GRAFT (BES) GROUP. THE STUDY INCLUDED 59 PATIENTS, 33 OF WHICH WERE TREATED WITH BES. DEATHS OCCURRED IN THE STUDY POPULATION. THERE WERE 17 CASES OF MORTALITY IN THE BES GROUP. SPECIFIC CAUSES OF DEATH WERE NOT INDIVI DUALLY REPORTED; DEATHS OCCURRED IN THE CONTEXT OF ADVANCED HEAD AND NECK CANCER WITH INTRACRANIAL CAROTID BLOWOUT SYNDROME. IT WAS NOTED THAT THERE WERE NO FATAL REBLEEDING EVENTS IN EITHER GROUP. AMONG PATIENT ADVERSE EVENTS INCLUDED: ¿ THERE WERE 5 REBLEEDING EVENTS IN THE BES GROUP, 4 OF WHICH INCLUDED EXTRAVASATION FROM THE REBLEEDING SITE. ¿ THERE WERE 5 NEUROLOGICAL COMPLICATIONS IN THE BES GROUP, INCLUDING FOUR DELAYED STROKE EVENTS AND ONE WITH SEPTIC THROMBOSIS AND A BRAIN ABSCESS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772914 REFLEX CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RFX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Death SEE H11.