BEUDAMED
    FDA Adverse Event Death Summary report: N

    AZURION

    MDR report key: 17199176 · Received June 26, 2023

    Report

    Report Number
    3003768277-2023-03824
    Event Type
    Death
    Date Received
    June 26, 2023
    Date of Event
    June 16, 2023
    Report Date
    May 8, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099272
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED, THE INCIDENT OCCURRED DURING A NEUROVASCULAR COILING IMPLANT PROCEDURE. THE PHYSICIAN REPORTED THAT, DURING THE PROCEDURE, THE ROADMAP* IMAGES WERE DARK, CAUSING DIFFICULTIES WITH VIEWING THE COIL IMPLANT. THE ROADMAP FUNCTIONALITY REQUIRED A RESET, WHICH CAUSED A LOSS OF VISUALIZATION OF THE COIL IMPLANT. AFTER THIS, THE COIL IMPLANT COULD NOT BE LOCATED IN THE PATIENT¿S ANATOMY. IT IS UNKNOWN IF THE PHYSICIAN WAS ABLE TO LOCATE, RETRIEVE, AND REMOVE THE COIL OR IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM ON SITE. TROUBLESHOOTING AND ANALYSIS OF THE SYSTEM'S LOG FILES CONFIRMED THE ISSUE WITH THE DARK ROADMAP IMAGES. WHEN USING THE ROADMAP FUNCTIONALITY, THE SYSTEM STORES CERTAIN IMAGING SETTINGS FROM THE DIGITAL SUBTRACTED ANGIOGRAPHY (DSA) IMAGE FOR OPTIMAL ROADMAPPING. IF A PEDAL IS PRESSED WHILE USING THE ROADMAP, THESE STORED SETTINGS ARE OVERWRITTEN, AND THE NEXT IMAGE COULD APPEAR DARKER WHEN COMPARED TO THE ORIGINAL ROADMAP. A SYSTEM SOFTWARE UPGRADE ADDRESSES THIS ISSUE AND IS SCHEDULED TO BE IMPLEMENTED ON THIS SYSTEM IN JUNE 2024. * ROADMAP PRO IS A FUNCTIONALITY OF THE AZURION SYSTEM THAT ALLOWS USERS TO SUPERIMPOSE THE LIVE IMAGE AND A MASK IMAGE OF THE VESSEL TREE TO IMPROVE VISIBILITY OF CATHETERS, DEVICES, AND MATERIALS. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. THE PATIENT OUTCOME CODE WAS CORRECTED.

    Additional Manufacturer Narrative · 0

    PHILIPS HAS RECEIVED THE FOLLOWING ADDITIONAL INFORMATION RELATED TO THIS COMPLAINT SINCE SUBMISSION OF THE SUPPLEMENTAL REPORT: THE INCIDENT OCCURRED DURING AN ENDOVASCULAR COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOMA) ANEURYSM ON 16 JUNE 2023. THE PATIENT HAD PRESENTED ON 15 JUNE 2023 WITH AN ACUTE SUBARACHNOID HEMORRHAGE AND WAS ADMITTED TO THE NEURO INTENSIVE CARE UNIT. IMAGING IDENTIFIED A 6 MM RUPTURED ACOMA ANEURYSM WITH ASSOCIATED HEMORRHAGE AND HYDROCEPHALUS. DURING THE PROCEDURE, A COIL MIGRATED INTO THE LEFT A2 SEGMENT, AND ATTEMPTS TO RETRIEVE THE MIGRATED COIL WERE UNSUCCESSFUL. THE ANEURYSM ITSELF WAS REPORTED AS SECURED, THE VESSEL REMAINED PATENT WITHOUT THROMBUS FORMATION, AND THE PATIENT WAS MANAGED CONSERVATIVELY WITH ASPIRIN. POST PROCEDURE IMAGING DEMONSTRATED PROGRESSION OF INTRACRANIAL HEMORRHAGE AND HYDROCEPHALUS. THE PATIENT EXPERIENCED GRADUAL CLINICAL DETERIORATION AND PASSED AWAY ON (B)(6) 2023. BASED ON INFORMATION FROM THE INSTITUTION, THE CAUSE OF DEATH WAS SPONTANEOUS SUBARACHNOID HEMORRHAGE DUE TO AN ACOMA ANEURYSM. THE SYSTEM SOFTWARE UPGRADE INTENDED TO CORRECT THE REPORTED SYSTEM BEHAVIOUR WAS SUCCESSFULLY IMPLEMENTED ON THE AFFECTED SYSTEM IN OCTOBER 2024. THE FDA ESTABLISHMENT REGISTRATION NUMBER [FEI] HAS BEEN UPDATED AND REPORTED TO THE FDA, CHANGING FROM 3003768277 TO 3042175844, EFFECTIVE DECEMBER 21, 2025. THIS CHANGE REFLECTS AS ADMINISTRATIVE REGISTRATION UPDATE ONLY. THERE HAVE BEEN NO CHANGES TO THE REGISTERED OWNER/OPERATOR, OFFICIAL CORRESPONDENT, LEGAL ENTITY NAME, PHYSICAL ESTABLISHMENT ADDRESS, MANUFACTURING PROCESSES, OR TO THE DESIGN, SPECIFICATIONS, INTENDED USE, OR MANUFACTURING PROCESSES OF ANY LISTED DEVICES.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A NEURO COILING PROCEDURE THE ROADMAP IMAGES WERE DARK WHICH REQUIRED A RESET. HARM TO THE PATIENT WAS REPORTED HOWEVER AT THIS TIME THE DETAILS ARE UNKNOWN. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628268 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 Other| D