BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20/10 & ALLURA XPER FD20/20

    MDR report key: 14344706 · Received May 10, 2022

    Report

    Report Number
    3003768277-2022-00221
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 15, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDTL NARRATIVE: PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE CUSTOMER ALLEGED TWO SIMILAR INCIDENTS WHERE NOISE WAS VISIBLE ON THE SCREEN JUST PRIOR TO GLUE INJECTION. ONE PROCEDURE WAS USING ONYX LIQUID EMBOLIC AND ONE USING SQUID LIQUID EMBOLIC. THIS COMPLAINT IS REGARDING THE PROCEDURE IN WHICH ONYX LIQUID EMBOLIC WAS USED. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED FROM THE CUSTOMER, WHEN THE CUSTOMER INJECTED THE ONYX LIQUID EMBOLIC AND INITIATED X-RAY VIA THE FOOT PEDAL, THE INJECTION COULD NOT BE CONTROLLED AS THE IMAGE WAS NOISY AND DID NOT SHOW THE PROGRESS OF THE EMBOLIC. WHEN THE IMAGE SUDDENLY ¿REFRESHED¿ A REFLUX OF EMBOLIC WAS NOTED, AND THEY STOPPED THE INJECTION OF EMBOLIC AND REVIEWED VIA ANGIOGRAPHY TO ENSURE THE ABSENCE OF THE REFLUX (EXTRA EMBOLIC) IN THE BASILAR TRUNK OF THE BRAIN. THE ISSUE HAPPENED DURING A CATHETERIZATION OF THE LEFT THALAMIC ARTERY FOR A RUPTURED LEFT THALAMIC ARTERIOVENOUS MALFORMATION (AVM). THERE WAS A DEMONSTRATED OCCLUSION OF THE RIGHT THALAMIC PERFORATING ARTERY BY THE REFLUX OF THE EMBOLIC WITH A SMALL THALAMIC STROKE NOTED. THIS RESULTED IN DELAYED AWAKENING OF THE PATIENT AND ALERTNESS DISORDERS IN THE FIRST DAYS AFTER EMBOLIZATION. THE PATIENT¿S EYE MOBILITY WAS REDUCED IN THE VERTICAL DIRECTION, THERE WAS A CHANGE FROM THE PATIENTS BASELINE OF INCREASED LETHARGY WHICH WAS ATTRIBUTED TO THE AVM RUPTURE, AND CONSEQUENT HEMORRHAGE AND THE THALAMIC ISCHEMIA MADE BY THE EMBOLIC REFLUX. PHILIPS HAS ANALYZED THE LOG FILE AND IMAGES AND INSPECTED THE SYSTEM ONSITE. ANALYSIS OF THE IMAGES CONFIRMED THE EMBOLIZATION OF HEALTHY TISSUE. NO FAILURE WAS FOUND IN THE LOG FILE OR VIA VISUAL INSPECTION OF THE SYSTEM. BASED ON THE ANALYSIS OF THE AVAILABLE INFORMATION PHILIPS HAS NOT BEEN ABLE TO DETERMINE THE ACTUAL ROOT CAUSE. PHILIPS PERFORMED A GOOD FAITH EFFORT TO COLLECT ADDITIONAL DETAILS ABOUT THE EVENT TO FURTHER INVESTIGATE THE ISSUE, HOWEVER THE CUSTOMER DID NOT RESPOND. AT THE REQUEST OF THE CUSTOMER, THE SYSTEM HAS BEEN UNINSTALLED ON APRIL 22, 2023. CORRECTED DATA: CODES ARE UPDATED AS PER THE INVESTIGATION OUTCOME.

    Additional Manufacturer Narrative · 0

    PHILIPS INSPECTED THE SYSTEM ONSITE AND REVIEWED LOG AND TRACE FILES. BASED ON PRELIMINARY RESULTS, NO MALFUNCTION OF THE SYSTEM HAS BEEN IDENTIFIED. PHILIPS IS FURTHER INVESTIGATING TO IDENTIFY THE CAUSE OF THE EVENT. CORRECTED DATA: CODES ARE UPDATED AS PER THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CEREBRAL AVM WITH THE PHILIPS ALLURA SYSTEM USING ONYX/SQUID LIQUID EMBOLIC, THERE WAS ¿POOR¿ VISUALIZATION. THE PHYSICIAN REPORTED THAT WHILE HE WAS INJECTING THE LIQUID EMBOLIZING TREATMENT INITIALLY, NOTHING WAS VISUALIZED. THEN THERE WAS A LOT OF THE PRODUCT THAT APPEARED ON THE SCREEN. THIS REPORTEDLY RESULTED IN EMBOLIZATION OF NON-INTENDED, HEALTHY TISSUE. ANOTHER OCCURRENCE WAS REPORTED BY PHILIPS ON (B)(6) 2022 (REFERENCE FAGG: (B)(4)). PHILIPS HAS BEEN INFORMED THAT ONE PATIENT WENT INTO COMA. AT THIS TIME IT IS UNKNOWN WHICH PATIENT WENT INTO COMA. PHILIPS HAS REQUESTED ADDITIONAL INFORMATION FROM THE USER AND HAS INITIATED AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566037 ALLURA XPER FD20/10 & ALLURA XPER FD20/20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10 & FD20/20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening