BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE Y-90 (11.5 GBQ)

    MDR report key: 20864517 · Received December 6, 2024

    Report

    Report Number
    2124215-2024-76697
    Event Type
    Death
    Date Received
    December 6, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    UDI-DI
    05060116921540
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3, MANUFACTURER ZIP/POSTAL: GU9 8QL. G1, MFR SITE ZIP/POST CODE: GU9 8QL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE AND PASSED AWAY. THIS PATIENT WAS ENROLLED IN THE EMERALD Y-90 STUDY AND TREATED WITH THERASPHERE ON (B)(6) 2024. THE THERASPHERE TREATMENT WENT SMOOTHLY AND EXACTLY AS PLANNED VIA LEFT RADIAL ARTERY APPROACH. AFTER TREATMENT, THE SITE REMOVED THE CATHETERS AND PUT THE RADIAL BAND ON. DURING THIS PROCESS, THE PATIENT STARTED BREATHING ABNORMALLY AND BECAME UNRESPONSIVE. THE PATIENT WAS INTUBATED FOR AIRWAY PROTECTION AND TAKEN TO THE MEDICAL INTENSIVE CARE UNIT (ICU). COMPUTED TOMOGRAPHY (CT) WAS PERFORMED OF THE HEAD AND THE CHEST/ABDOMEN/PELVIS WITH NOTHING NOTABLE. MAGNETIC RESONANCE IMAGING (MRI) AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) OF THE HEAD REVEALED A BASILAR ARTERY OCCLUSION AND LARGE POSTERIOR CIRCULATION STROKE, THUS A THROMBECTOMY WAS PERFORMED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS POOR AND CLINICALLY UNIMPROVED AFTER THE THROMBECTOMY. THE PATIENT WAS PLACED ON COMFORT CARE, BUT ULTIMATELY THE FAMILY MADE THE DECISION TO PLACE ON DO NOT RESUSCITATE / DO NOT INTUBATE (DNR/DNI) AND TERMINALLY EXTUBATED. THE PATIENT PASSED AWAY (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119685 THERASPHERE Y-90 (11.5 GBQ) MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-03 05060116921540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| D