BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIST

    MDR report key: 23272163 · Received October 10, 2025

    Report

    Report Number
    2029214-2025-02168
    Event Type
    Death
    Date Received
    October 10, 2025
    Report Date
    October 10, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A2, A3A: NOTE THAT THE PATIENT INFORMATION IS REFLECTIVE OF THE MEAN OF THAT IN THE THE AGGREGATED DATA. G2: OTHER - RIST AGGREGATE DATA REPORT RECEIVED FROM FIVOS INC. 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

    MEDTRONIC RECEIVED AGGREGATED DATA ABOUT THE EXPERIENCES OF 331 PATIENTS WHO UNDERWENT PROCEDURES INVOLVING A RIST CATHETER FOR TREATMENT OF ANEURYSMS. 6 PATIENT DEATHS WERE RELATED TO DISEASE OR TREATMENT. FOLLOW-UP OUTCOMES REPORTED CURRENT LIVING STATUS 2 PATIENTS WITH DEATH BEING RELATED TO DISEASE OR TREATMENT. 2 PATIENTS EXPERIENCED ANEURYSM INTRA-PROCEDURAL RUPTURE. 1 PATIENT EXPERIENCED DISTAL EMBOLIZATION. 6 PATIENTS EXPERIENCED THROMBUS FORMATION. 1 PATIENT EXPERIENCED VASOSPASM (SUBARACHNOID HEMORRHAGE (SAH) INDUCED). 4 PATIENTS EXPERIENCED VASOSPASM (SAH INDUCED) - DELAYED CEREBRAL ISCHEMIA. 1 PATIENT EXPERIENCED VESSEL DISSECTION. 1 PATIENT EXPERIENCED VESSEL OCCLUSION. 1 PATIENT EXPERIENCED DEVICE FRACTURE/FAILURE. 5 PATIENTS EXPERIENCED ELEVATED ELEVATED INTRACRANIAL PRESSURE (ICP) (>25MM HG FOR >20 MIN). 6 PATIENTS EXPERIENCED HYDROCEPHALUS. 1 PATIENT EXPERIENCED NEW INTRACRANIAL HEMORRHAGE ON IMAGING (IPH/IVH/SAH/SDH). FOLLOW UP CT REVEALED SYMPTOMATIC HEMORRHAGE IN 1 PA TIENT. 7 PATIENTS EXPERIENCED NEW STROKE OR INFARCT. OF PATIENTS WITH STROKE 5 WERE MINOR AND 1 WAS MAJOR. FOLLOW UP CT FINDINGS REVEALED STROKE IN 1 PATIENT. FOLLOW UP MRI FINDINGS REVEALED STROKE IN 2 PATIENTS. OF STROKES REVEALED IN FOLLOW UP, 2 WERE MINOR, 1 WAS MAJOR. 3 PATIENTS EXPERIENCED NEW SEIZURE. 1 PATIENT EXPERIENCED POST-OP NEW SYMPTOMATIC INTRACEREBRAL HEMORRHAGE (ICH). 1 PATIENT EXPERIENCED THROMBOTIC EVENTS (NON-NEUROLOGIC) DEEP-VEIN THROMBOSIS (DVT). 1 PATIENT EXPERIENCED ACCESS SITE COMPLICATION OF ACCESS SITE INFECTION/INFLAMMATORY REACTION. 1 PATIENT EXPERIENCED ACCESS SITE COMPLICATION OF "OTHER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280806 RIST CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-RIST UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death| O