BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 21698854 · Received March 26, 2025

    Report

    Report Number
    3003768277-2025-002797
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    October 19, 2024
    Report Date
    March 27, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099272
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THE REPORTED ISSUE. TECHNICAL LOG FILE ANALYSIS CONFIRMED THE FOLLOWING SEQUENCE OF EVENTS: IMAGE FLICKERING, DOSE INCREASE, DEVICE RESET (ROADMAP RESET),STENT NOT VISIBLE. TO ADDRESS THE IMAGE FLICKERING, A FIELD SERVICE ENGINEER ENABLED A KV (KILOVOLT) LOCK IN THE SYSTEM DATABASE. THE ROADMAP RESET OCCURRED AS DESIGNED WHEN THE DOSE WAS CHANGED (LIKELY THE USER¿S WAY OF TROUBLESHOOTING THE IMAGE FLICKERING), RECREATING THE LIVEFLUOMASK (LFM)*. THE STENT WAS CONSIDERED PART OF THE RECREATED LFM AND REMOVED FROM THE SUBTRACTED IMAGE, MAKING IT INVISIBLE TO THE OPERATOR. AS NO SYSTEM MALFUNCTION WAS IDENTIFIED, PHILIPS IMPLEMENTED UPDATES TO THE INSTRUCTIONS FOR USE (IFU) AND TRAINING CONTENT TO HIGHLIGHT THE ROADMAP RESET FUNCTIONALITY. THE PATIENT RECOVERED AS EXPECTED. * LFM IS A BACKGROUND REFERENCE IMAGE/ MASK IMAGE OF THE VESSELS, WHICH ROADMAPLIVEFLUO OVERLAYS WITH REAL-TIME FLUOROSCOPY IMAGES (SHOWING CATHETERS, WIRES, STENTS), ALLOWING THE OPERATOR TO NAVIGATE DEVICES INSIDE THE VESSELS WITHOUT RE-INJECTING CONTRAST. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. THE SERIAL NUMBER AND THE PRODUCT UD HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THE REPORTED ISSUE. TECHNICAL LOG FILE ANALYSIS CONFIRMED THE FOLLOWING SEQUENCE OF EVENTS: IMAGE FLICKERING, DOSE INCREASE, DEVICE RESET (ROADMAP RESET),STENT NOT VISIBLE. TO ADDRESS THE IMAGE FLICKERING, A FIELD SERVICE ENGINEER ENABLED A KV (KILOVOLT) LOCK IN THE SYSTEM DATABASE. THE ROADMAP RESET OCCURRED AS DESIGNED WHEN THE DOSE WAS CHANGED (LIKELY THE USER¿S WAY OF TROUBLESHOOTING THE IMAGE FLICKERING), RECREATING THE LIVEFLUOMASK (LFM)*. THE STENT WAS CONSIDERED PART OF THE RECREATED LFM AND REMOVED FROM THE SUBTRACTED IMAGE, MAKING IT INVISIBLE TO THE OPERATOR. AS NO SYSTEM MALFUNCTION WAS IDENTIFIED, PHILIPS IMPLEMENTED UPDATES TO THE INSTRUCTIONS FOR USE (IFU) AND TRAINING CONTENT TO HIGHLIGHT THE ROADMAP RESET FUNCTIONALITY. THE PATIENT RECOVERED AS EXPECTED. LFM IS A BACKGROUND REFERENCE IMAGE/ MASK IMAGE OF THE VESSELS, WHICH ROADMAPLIVEFLUO OVERLAYS WITH REAL-TIME FLUOROSCOPY IMAGES (SHOWING CATHETERS, WIRES, STENTS), ALLOWING THE OPERATOR TO NAVIGATE DEVICES INSIDE THE VESSELS WITHOUT RE-INJECTING CONTRAST. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING THE DEPLOYMENT OF A PLANNED FLOW-DIVERTING STENT OF A RUPTURED, DISSECTING VERTEBRAL ARTERY ANEURYSM, A ROADMAP RESET OCCURRED RESULTING IN THE STENT DEVICE "BLANKING OUT". THE REPORT FURTHER INDICATED "SOME SHAKING AND FLICKERING OF MACHINE" AND VISIBILITY ISSUES. THE STENT WAS DEPLOYED AND SUBSEQUENTLY MIGRATED TO THE BASILAR ARTERY. ATTEMPTS WERE MADE BY THE PHYSICIAN TO RECAPTURE THE STENT BUT WERE UNSUCCESSFUL. IT WAS FURTHER REPORTED THAT SUBSEQUENT THROMBUS FORMATION AROUND THE STENT WAS TREATED SATISFACTORILY WITH ANTIPLATELETS AND THAT THE ANEURYSM WAS SUBSEQUENTLY SECURED WITH VESSEL SACRIFICE. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803836 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838099272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention