BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALLURA XPER FD20

    MDR report key: 24078624 · Received January 15, 2026

    Report

    Report Number
    24078624
    Event Type
    Death
    Date Received
    January 15, 2026
    Date of Event
    June 27, 2025
    Report Date
    January 14, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    OWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING PLACEMENT OF THE TARGET COIL, ON THE FIRST TWO ATTEMPTS, THE INTERVENTIONALIST COULD NOT SEE THE COILS BEING DEPLOYED BECAUSE THE IMAGES WERE NOT LIVE AND WHEN THEY COULD SEE, THE COIL LOOPS WERE IN THE ICA (INTERNAL CAROTID ARTERY). ON THE THIRD ATTEMPT, WHEN THE COIL LOOPS WERE PLACED UNDER BALLOON OCCLUSION, THE COIL LOOPS WERE SEEN TO EXTEND INTO THE PCOM (POSTERIOR COMMUNICATING ARTERY) ORIGIN/THROUGH THE DOME OF THE ANEURYSM. AT A CRUCIAL POINT IN THE PROCEDURE, THE NEURO-INTERVENTIONALIST WAS UNABLE OR HAD DIFFICULTY SEEING THE ¿ROADMAP¿ IMAGE. THE CAUSE OF THIS IS UNCLEAR. THERE IS DISAGREEMENT AMONG THOSE INVOLVED REGARDING THE CASE BEING EQUIPMENT FAILURE VS OPERATOR ERROR. IT IS NOT CLEAR OR CERTAIN THAT THIS DIRECTLY LEAD TO INTRA-OPERATIVE COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141369 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS ALLURA XPER FD20 BIPLANE 722008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death