BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 10187867 · Received June 24, 2020

    Report

    Report Number
    3002124543-2020-00016
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 8, 2020
    Report Date
    May 26, 2020
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY MEDICAL ASSESSMENT COMMENTS: THE REPORTED ADVERSE EVENTS ARE KNOWN INHERENT RISKS ASSOCIATED WITH SIRT LISTED IN THE IFU/RISK MANAGEMENT DOCUMENTATION. NO DEVICE MALFUNCTION WAS REPORTED OR IDENTIFIED. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE BATCH NUMBER HAS NOT BEEN PROVIDED AND THE PRODUCT WAS NOT RETURNED FOR EVALUATION (DEVICE REMAINS IMPLANTED IN THE PATIENT). NO CORRECTIVE/PREVENTATIVE ACTION HAS BEEN IDENTIFIED. SHOULD WE RECEIVE ANY INFORMATION TO ENABLE FURTHER INVESTIGATIONS, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME THIS REPORT I CONSIDERED FINAL.

    Description of Event or Problem · 1

    AUTONOTIFICATION RECEIVED FROM (B)(6) 26-MAY-2020 AS FOLLOWS: SITE NUMBER : (B)(6), UNIQUE PATIENT ID : (B)(6), DIAGNOSTIC TERM TO DESCRIBE PRIMARY SAE: ASCITIS, SERIOUSNESS CRITERIA (SAECRIT): LED TO A SERIOUS DETERIORATION IN HEALTH, START DATE: (B)(6) 2020, SEVERITY (CTCAE V5.0 GRADE): GRADE 2, CAUSALITY RELATED TO ADMINISTRATION PROCEDURE: NOT RELATED, CAUSALITY RELATED TO THERASPHERE DEVICE: DEFINITELY. (B)(6) MALE PATIENT. OBESE PATIENT WITH A BMI OF 35.4, (B)(6) KG. DIAGNOSES WITH HCC (B)(6) 2020, ETIOLOGY OF UNDERLYING LIVER DISEASE: ALCOHOL, DYSMETABOLIC. TUMOUR CHARACTERISTICS: MULTIFOCAL, 2-4 LESIONS 4 MM DIAMETER INDEX LESION IN, RIGHT LIVER SEGMENT VIII, PRESENCE OF PVT (TUMOURAL), TUMOR BURDEN 10%, NO EHD. NO PRIOR ANTI-CANCER TREATMENTS RECEIVED. MAIN COMORBIDITIES: HYPERGLYCEMIA, DIABETES, CORONARY ARTERIAL DISEASE, ALCOHOL INTAKE HISTORY, TOBACCO INTAKE HISTORY, RENAL DISEASE. THERASPHERE TREATMENT - (B)(6) 2020 3.78 GBQ ADMINISTERED TO RIGHT LIVER VIA FEMORAL ARTERY. IT WAS NOTED: SIGNIFICANTLY HIGHER OVERALL PERFUSION IN TUMOUR VERSUS NORMAL LIVER. COMPLETE DISTRIBUTION (Y90 DISTRIBUTION IN 99-100% THE ALL/NEAR ALL THE TUMOUR VOLUME). EVENT: ON THE (B)(6) 2020 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE OCCURRENCE OF ASCITES, OEDEMA, WORSENING OF RENAL FUNCTION, AND HYPOXEMIA, CHILD B9. ACTION TAKEN: CONCOMITANT MEDICATION. OXYGEN, ASCITES REMOVAL. DISCHARGED: (B)(6) 2020. INTERVENTION: EVACUATION OF THE PERITONEAL FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651788 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT NAW BIOCOMPATIBLES UK LTD 3.78GBQ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R