THERASPHERE Y-90 (4 GBQ)
Report
- Report Number
- 2124215-2025-19057
- Event Type
- Injury
- Date Received
- March 27, 2025
- Date of Event
- February 24, 2025
- Report Date
- July 1, 2025
- Manufacturer
- BIOCOMPATIBLES UK LIMITED
- Product Code
- NAW
- UDI-DI
- 05060116920352
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D3, MANUFACTURER ZIP/POSTAL: GU9 8QL. G1, MFR SITE ZIP/POST CODE: GU9 8QL. THE LOT NUMBER WAS NOT PROVIDED FROM THE CLINICAL STUDY, THUS UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION.
D3, MANUFACTURER ZIP/POSTAL: (B)(6). G1, MFR SITE ZIP/POST CODE: (B)(6). THE LOT NUMBER WAS NOT PROVIDED FROM THE CLINICAL STUDY, THUS UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION.
D3, MANUFACTURER ZIP/POSTAL: (B)(6), G1, MFR SITE ZIP/POST CODE: (B)(6). THE LOT NUMBER WAS NOT PROVIDED FROM THE CLINICAL STUDY, THUS UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RADIOEMBOLIZATION-INDUCED LIVER DISEASE THAT WAS TREATED WITH MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER 143 GY AND DOSE TO TOTAL NORMAL TISSUE WAS CURRENTLY UNAVAILABLE. LUNG SHUNT CALCULATION WAS 0 PERCENT. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED TO THE LIVER WAS LOBAR (2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 1 DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS REPORTED AS 1.613 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION AND AVID UPTAKE IN ALL LESION?S DISTRIBUTION OF Y90 ON TUMORS. THE DOSE TO PERFUSED LIVER NORMAL TISSUE WAS 361 GY AND DOSE TO LIVER NORMAL TISSUE WAS 26 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 39 DAYS POST THE THERASPHERE ADMINISTRATION SUBJECT NOTED WITH RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD) AND WAS TREATED MEDICALLY WITH PREDNISOLONE (60 MG /ORAL DAILY).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RADIOEMBOLIZATION-INDUCED LIVER DISEASE THAT WAS TREATED WITH MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER 143 GY AND DOSE TO TOTAL NORMAL TISSUE WAS CURRENTLY UNAVAILABLE. LUNG SHUNT CALCULATION WAS 0 PERCENT. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED TO THE LIVER WAS LOBAR (2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 1 DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS REPORTED AS 1.613 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION AND AVID UPTAKE IN ALL LESION DISTRIBUTION OF Y90 ON TUMORS. THE DOSE TO PERFUSED LIVER NORMAL TISSUE WAS 361 GY AND DOSE TO LIVER NORMAL TISSUE WAS 26 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 39 DAYS POST THE THERASPHERE ADMINISTRATION SUBJECT NOTED WITH RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD) AND WAS TREATED MEDICALLY WITH PREDNISOLONE (60 MG /ORAL DAILY). ADDITIONAL INFORMATION WAS REPORTED TWO NEW ADDITIONAL ADVERSE EVENTS; ANEMIA ON (B)(6) 2025 AND AN INCREASE IN ALBUMIN ON (B)(6) 2025. NO ACTIONS TAKEN WERE TAKEN TO TREAT EITHER NEW EVENT; HOWEVER, IT WAS NOTED THAT THE SUBJECT WAS STILL TAKING PREDNISOLONE (20 MG/ORAL DAILY) FOR THE EVENT OF REILD.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED RADIOEMBOLIZATION-INDUCED LIVER DISEASE THAT WAS TREATED WITH MEDICATION. THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY ON (B)(6) 2025. PRE-TREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS, DOSE TO PERFUSED LIVER 143 GY AND DOSE TO TOTAL NORMAL TISSUE WAS CURRENTLY UNAVAILABLE. LUNG SHUNT CALCULATION WAS 0 PERCENT. ON (B)(6) 2025, THE TREATMENT WITH THERASPHERE WAS PERFORMED TO THE LIVER WAS LOBAR (2 SEGMENTS IN THE PERFUSED VOLUME) THROUGH FEMORAL ARTERY AND 1 DOSE VIAL WAS ADMINISTERED; TOTAL ADMINISTERED ACTIVITY DOSE WAS REPORTED AS 1.613 GBQ. POST TREATMENT DOSIMETRY DOCUMENTED BETWEEN AVID UPTAKE IN TARGET LESION AND AVID UPTAKE IN ALL LESION DISTRIBUTION OF Y90 ON TUMORS. THE DOSE TO PERFUSED LIVER NORMAL TISSUE WAS 361 GY AND DOSE TO LIVER NORMAL TISSUE WAS 26 GY. LUNG DOSE CALCULATION WAS 0. ON (B)(6) 2025, COMBINATION THERAPY WITH 1500 MG DURVALUMAB FOLLOWED BY 300 MG OF TREMELIMUMAB WERE ADMINISTERED INTRAVENOUSLY. ON (B)(6) 2025, 39 DAYS POST THE THERASPHERE ADMINISTRATION SUBJECT NOTED WITH RADIOEMBOLIZATION-INDUCED LIVER DISEASE (REILD) AND WAS TREATED MEDICALLY WITH PREDNISOLONE (60 MG /ORAL DAILY). ADDITIONAL INFORMATION WAS REPORTED TWO NEW ADDITIONAL ADVERSE EVENTS; ANEMIA ON (B)(6) 2025 AND AN INCREASE IN ALBUMIN ON (B)(6) 2025. NO ACTIONS TAKEN WERE TAKEN TO TREAT EITHER NEW EVENT; HOWEVER, IT WAS NOTED THAT THE SUBJECT WAS STILL TAKING PREDNISOLONE (20 MG/ORAL DAILY) FOR THE EVENT OF REILD. ADDITIONAL INFORMATION WAS AGAIN REPORTED THAT CLARIFIED THAT THE EVENT ON 10-MAR-25 WAS A DECREASE IN ALBUMIN (NOT INCREASE). IT ALSO REPORTED ON (B)(6) 2025 THERE WAS AN INCREASE IN BILIRUBIN. NO ACTIONS WERE TAKEN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2530287 | THERASPHERE Y-90 (4 GBQ) | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LIMITED | 2361-02 | 05060116920352 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |