BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 10659499 · Received October 9, 2020

    Report

    Report Number
    3002124543-2020-00018
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    July 26, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    UDI-DI
    05060116920284
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL ASSESSMENT DOCUMENTED THAT THE ABDOMINAL PAIN, FEVER, CONFUSION WERE SERIOUS ADVERSE EVENTS THAT LED TO HOSPITAL ADMISSION, WHEREAS THE REPORTED ANOREXIA DID NOT RESULT IN HOSPITALISATION. THE MEDICAL ASSESSMENT BELIEVES THAT ALL FOUR REPORTED ADVERSE EVENTS ARE GRADE 3 (AS DESCRIBED IN THE CTCAE V5.0). THE MEDICAL ASSESSMENT CONCURS THAT ALL REPORTED ADVERSE EVENTS ARE RELATED TO THE THERASPHERE DEVICE. ANOREIA, ABDOMINAL PAIN, FEVER AND CONFUSION ARE ALL LISTED AS POTENTIAL ADVERSE EVENTS IN THE PRODUCT LABELLING, AND ARE THEREFORE KNOWN RISKS ASSOCIATED WITH THE USE OF THERASPHERE.

    Description of Event or Problem · 0

    PATIENT (B)(6) WITH A HCC TUMOUR IN SEGMENT VIII OF THE RIGHT LIVER WAS ENROLLED IN THE PROACTIF REGISTRY STUDY ON (B)(6) 2020. THE PATIENT RECEIVED THERASPHERE ADMINISTRATION ON THE SAME DAY TO THE RIGHT LIVER. THE PERFUSED LIVER VOLUME AND ABSORBED DOSE HAS NOT BEEN REPORTED. ON (B)(6) 2020 (45 DAYS POST THERASPHERE ADMINISTRATION), THE PATIENT PRESENTED WITH FEVER (38.2 C), ABDOMINAL PAIN AND COGNITIVE DISTURBANCE. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT, AND WAS TREATED WITH ANTIBIOTICS AND SURGICAL INTERVENTION. THE PATIENT ALSO PRESENTED IN (B)(6) 2020 WITH ANOREXIA (GRADE 3), WHICH WAS ALSO ASSESSED TO BE RELATED TO THERASPHERE PROCEDURE, BUT NO ACTION WAS TAKEN TO RESOLVE THE ANOREXIA. THE PHYSICIAN ASSESSED THE ABDOMINAL PAIN AND COGNITIVE DISTURBANCE AS A GRADE 2 SERIOUS ADVERSE EVENT (AS DEFINED IN THE CTCAE V5.0 ADVERSE EVENT REPORTING GUIDELINE, AND AS PROBABLY RELATED TO THE THERASPHERE ADMINISTRATION PROCEDURE.

    Description of Event or Problem · 1

    PATIENT (B)(6) WITH A HCC TUMOUR IN SEGMENT VIII OF THE RIGHT LIVER WAS ENROLLED IN THE (B)(6) REGISTRY STUDY ON (B)(6) 2020. THE PATIENT RECEIVED THERASPHERE ADMINISTRATION ON THE SAME DAY TO THE RIGHT LIVER. THE PERFUSED LIVER VOLUME AND ABSORBED DOSE HAS NOT BEEN REPORTED. ON (B)(6) 2020 (45 DAYS POST THERASPHERE ADMINISTRATION), THE PATIENT PRESENTED WITH FEVER (38.2 C), ABDOMINAL PAIN AND COGNITIVE DISTURBANCE. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT, AND WAS TREATED WITH ANTIBIOTICS AND SURGICAL INTERVENTION. THE PATIENT ALSO PRESENTED IN (B)(6) 2020 WITH ANOREXIA (GRADE 3), WHICH WAS ALSO ASSESSED TO BE RELATED TO THERASPHERE PROCEDURE, BUT NO ACTION WAS TAKEN TO RESOLVE THE ANOREXIA. THE PHYSICIAN ASSESSED THE ABDOMINAL PAIN AND COGNITIVE DISTURBANCE AS A GRADE 2 SERIOUS ADVERSE EVENT (AS DEFINED IN THE CTCAE V5.0 ADVERSE EVENT REPORTING GUIDELINE, AND AS PROBABLY RELATED TO THE THERASPHERE ADMINISTRATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120554 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW BIOCOMPATIBLES UK LTD 990700.SPE 05060116920284

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R