THERASPHERE Y-90
Report
- Report Number
- 2124215-2024-54421
- Event Type
- Death
- Date Received
- September 3, 2024
- Date of Event
- January 20, 2022
- Report Date
- May 6, 2025
- Manufacturer
- BIOCOMPATIBLES UK LIMITED
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D3 & G1: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3 & G1: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. E1 INITIAL REPORTER ADDRESS 1: (B)(6).
D3 & G1: MANUFACTURER ZIP/POSTAL CODE: (B)(6) E1 INITIAL REPORTER ADDRESS 1: (B)(6) THE UPN AND LOT NUMBERS WERE NOT PROVIDED BY THE STUDY; THUS, THE UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS NOT AVAILABLE.
D3 & G1: MANUFACTURER ZIP/POSTAL CODE: (B)(6). E1 INITIAL REPORTER ADDRESS 1: (B)(6). THE UPN AND LOT NUMBERS WERE NOT PROVIDED BY THE STUDY; THUS, THE UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS NOT AVAILABLE.
IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED FOR TREATMENT OF OEDEMA DECOMPENSATION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE SELECTIVE LIVER. POST TREATMENT DOSIMETRY WAS NOT DETERMINED. ON (B)(6) 2022, 223 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH OEDEMA DECOMPENSATION. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO EMERGENCY DUE TO ALTERATION OF GENERAL CONDITION. DURING THE HOSPITALIZATION ASCITES WITH SIGNIFICANT LOWER LIMB EDEMA WAS DIAGNOSED, THUS DIURETICS WERE ADMINISTERED, AND REGULAR ASCITES PUNCTURE WAS PERFORMED TO TREAT THE EVENT. ADDITIONALLY, MAINTENANCE OF DIURETICS WAS ALSO PRESCRIBED. ON (B)(6) 2022, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.
IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED FOR TREATMENT OF OEDEMA DECOMPENSATION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE SELECTIVE LIVER. POST TREATMENT DOSIMETRY WAS NOT DETERMINED. ON (B)(6) 2022, 223 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH OEDEMA DECOMPENSATION. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO EMERGENCY ROOM DUE TO ALTERATION OF THEIR GENERAL CONDITION. DURING THE HOSPITALIZATION ASCITES WITH SIGNIFICANT LOWER LIMB EDEMA WAS DIAGNOSED, THUS DIURETICS WERE ADMINISTERED, AND REGULAR ASCITES PUNCTURE WAS PERFORMED TO TREAT THE EVENT. ADDITIONALLY, MAINTENANCE OF DIURETICS WAS ALSO PRESCRIBED. ON (B)(6) 2022, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT THE CATHETER POSITIONING DURING THE ADMINISTRATION PROCEDURE ON (B)(6) 2021 WAS NOT DOCUMENTED. TWO VIALS WERE ADMINISTERED TO THE PATIENT; 4.72 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1 AND 4.56 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 2. TOTAL THERASPHERE ACTIVITY ADMINISTERED TO THE SELECTIVE LIVER WAS 9.28 GBQ. POST-DISCHARGE IN (B)(6) 2022, THE SUBJECT HAS HAD PERSISTENT ASCITES OF GREAT ABUNDANCE (ECOG, 2), WHICH WAS TREATED WITH REPEATED PUNCTURE. ON (B)(6) 2022, THE SUBJECT PASSED AWAY DUE TO PROGRESSION OF LIVER DISEASE AND NOT DUE TO THE PROGRESSION OF THEIR CANCER WHERE THEIR HEPATOPATHY WAS DECOMPENSATED AS A RESULT OF RADIO-EMBOLIZATION.
IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED FOR TREATMENT OF OEDEMA DECOMPENSATION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE SELECTIVE LIVER. POST TREATMENT DOSIMETRY WAS NOT DETERMINED. ON (B)(6) 2022, 223 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH OEDEMA DECOMPENSATION. ON THE SAME DAY, THE SUBJECT WAS ADMITTED TO EMERGENCY ROOM DUE TO ALTERATION OF THEIR GENERAL CONDITION. DURING THE HOSPITALIZATION ASCITES WITH SIGNIFICANT LOWER LIMB EDEMA WAS DIAGNOSED, THUS DIURETICS WERE ADMINISTERED, AND REGULAR ASCITES PUNCTURE WAS PERFORMED TO TREAT THE EVENT. ADDITIONALLY, MAINTENANCE OF DIURETICS WAS ALSO PRESCRIBED. ON (B)(6) 2022, THE OUTCOME OF THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT THE CATHETER POSITIONING DURING THE ADMINISTRATION PROCEDURE ON (B)(6) 2021 WAS NOT DOCUMENTED. TWO VIALS WERE ADMINISTERED TO THE PATIENT; 4.72 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1 AND 4.56 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 2. TOTAL THERASPHERE ACTIVITY ADMINISTERED TO THE SELECTIVE LIVER WAS 9.28 GBQ. POST-DISCHARGE IN (B)(6) 2022, THE SUBJECT HAS HAD PERSISTENT ASCITES OF GREAT ABUNDANCE (ECOG, 2), WHICH WAS TREATED WITH REPEATED PUNCTURE. ON (B)(6) 2022, THE SUBJECT PASSED AWAY DUE TO PROGRESSION OF LIVER DISEASE AND NOT DUE TO THE PROGRESSION OF THEIR CANCER WHERE THEIR HEPATOPATHY WAS DECOMPENSATED AS A RESULT OF RADIO-EMBOLIZATION. FOLLOW-UP INFORMATION WAS PROVIDED WITH ADDITIONAL DETAILS THAT OCCURRED BETWEEN (B)(6) 2022 AND WHEN THE PATIENT PASSED AWAY. THE PATIENT WAS SEEN AT A FOLLOW-UP VISIT ON (B)(6) 2021 DUE TO FATIGUE. FROM (B)(6) 2022, THE PATIENT WAS OBSERVED FOR DYSPNEA AND FATIGUE, WHERE THE EXPLORATION CONCLUDED LIVER DECOMPENSATION WITH ASCITES AND OEDEMA, HYPOALBUMINEMIA 25G/L (BUT NORMAL BILIRUBIN). THE CT SCAN DID NOT IDENTIFY A TUMOR BUT SIRT SEQUELAE, ASCITES, LARGE PELVIC AND ABDOMINAL VEIN, AND LARGE UMBILICAL VEIN. PATIENT WAS DISCHARGED WITH "DIURETICS" ON (B)(6) 2020 (AS PREVIOUSLY REPORTED). ON (B)(6) 2022 A FOLLOW-UP PROVIDED THE PATIENT HAD DETERIORATED, ECOG2, NO CLINICAL ASCITES, LOWER LIMB OEDEMA. ON (B)(6) 2022 A CT SCAN DID NOT IDENTIFY A TUMOR BUT SIRT SEQUELAE AND ASCITES. THE PATIENT UNDERSTOOD THAT WITH THEIR LIVER FUNCTION DETERIORATION NO MORE TREATMENT WAS PROPOSED AND WAS PLACED ON IN-HOME SUPPORTIVE CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 899739 | THERASPHERE Y-90 | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Death| H| R |