BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 24651541 · Received March 20, 2026

    Report

    Report Number
    2029214-2026-00489
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    October 20, 2025
    Report Date
    March 20, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    PMA / PMN Number
    K180715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IKEDA H, KINOSADA M, AKAIKE N, ET AL. THROMBECTOMY USING A COMBINED TECHNIQUE WITH A MORE FLEXIBLE ASPIRATION CATHETER. CLINICAL NEUROLOGY AND NEUROSURGERY. 2025;259. DOI:10.1016/J.CLINEURO.2025.109201 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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

    2026-FEB-24 LIT (FOR, LIT): IKEDA H, KINOSADA M, AKAIKE N, ET AL. THROMBECTOMY USING A COMBINED TECHNIQUE WITH A MORE FLEXIBLE ASPIRATION CATHETER. CLINICAL NEUROLOGY AND NEUROSURGERY. 2025;259. DOI:10.1016/J.CLINEURO.2025.109201 LITERATURE WAS REVIEWED REGARDING THROMBECTOMY USING A COMBINED TECHNIQUE WITH A MORE FLEXIBLE ASPIRATION CATHETER TO EVALUATE THE R ELATIONSHIP BETWEEN ASPIRATION CATHETER FLEXIBILITY AND CLINICAL OUTCOMES IN PATIENTS WITH ACUTE ISCHEMIC STROKE. THE TIME FRAME OF THIS STUDY WAS JANUARY 2020 THROUGH DECEMBER 2023. THE FOLLOWING MEDTRONIC DEVICES WERE USED: REACT 71 ASPIRATION CATHETER AND REACT 68 ASPIRATION CATHETER. DEATHS OCCURRED IN THE STUDY POPULATION. THE STUDY REPORTED OVERALL CLINICAL OUTCOMES INCLUDING MODIFIED RANKIN SCALE SCORES AT 90 DAYS; HOWEVER, SPECIFIC CAUSES OF DEATH AND THE NUMBER OF DEATHS WERE NOT EXPLICITLY REPORTED IN THE PUBLICATION. TECHNICAL ISSUES INCLUDED: -ASPIRATION CATHETER (AC) NAVIGATION TO THE PROXIMAL END OF THROMBUS IN THE FIRST PASS WAS SIGNIFICANTLY MORE COMMON IN THE MFAC (MORE FLEXIBLE ASPIRATION CATHETER) GROUP THAN IN THE NON-MFAC GROUP (75.6 % VS. 34.4 %). AMONG PATIENT ADVERSE EVENTS INCLUDED: -87 INTRACRANIAL HEMORRHAGES; 17 SYMPTOMATIC -78 SUBARACHNOID HEMORRHAGES -8 TYPE 1 PARENCHYMAL HEMATOMA -10 TYPE 2 PARENCHYMAL HEMATOMA -12 VESSEL INJURIES WITH CONTRAST EXTRAVASATION -3 IATROGENIC ARTERIAL DISSECTIONS -FINAL MTICI WAS 0 IN 12 PATIENTS, 1 IN 5 PATIENTS, 2A IN 10 PATIENTS, 2B IN 100 PATIENTS, 2C IN 42 PATIENTS, AND 3 IN 161 PATIENTS -118 PATIENTS HAD MRS SCORE 0¿2 AT 90 DAYS, AND 163 WITH MRS SCORE 0¿3 AT 90 DAYS NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716342 REACT CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 REACT-68 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death