THERASPHERE Y-90 (12.5 GBQ) CN CLINICAL
Report
- Report Number
- 2124215-2024-69064
- Event Type
- Injury
- Date Received
- November 7, 2024
- Date of Event
- September 29, 2024
- Report Date
- December 11, 2024
- Manufacturer
- BIOCOMPATIBLES UK LIMITED
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 59 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: GU9 8QL.
A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 59 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: GU9 8QL.
MANDARIN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ABDOMINAL PAIN AND NAUSEA AND REQUIRED MEDICATION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED IN THE MANDARIN STUDY. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 190 CM3. 8.02 GBQ WAS ADMINISTERED THROUGH ONE VIAL. TOTAL ACTIVITY DELIVERED TO THE SUBJECT AT THE TIME OF TREATMENT WAS 2.48 GBQ. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.129 GBQ AND RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 600 GY. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. TARGET VOLUME WAS 123.3 CM3. 12.5 GBQ WAS ADMINISTERED THROUGH ONE VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.24 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 1.59 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 624 GY AND RADIATION DOSE TO LUNGS WAS 12 GY. ON (B)(6) 2024, 101 DAYS POST INDEX PROCEDURE AND THE SAME DAY OF RE-TREATMENT, THE SUBJECT EXPERIENCED ABDOMINAL PAIN AND NAUSEA. FLURBIPROFEN AXETIL INJECTION WAS GIVEN, AND COMPOUND CODEINE PHOSPHATE AND IBUPROFEN SUSTAINED RELEASE TABLETS WERE ADMINISTERED AS A CORRECTIVE ACTION FOR THE ABDOMINAL PAIN. ADDITIONALLY, MEDICATION WAS ADMINISTERED, OR REGIMEN WAS ADJUSTED TO TREAT THE NAUSEA. IT WAS FURTHER REPORTED THAT THE NAUSEA WAS RESOLVED ON (B)(6) 2024, AND THE ABDOMINAL PAIN WAS RESOLVED ON (B)(6) 2024.
MANDARIN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED ABDOMINAL PAIN AND NAUSEA AND REQUIRED MEDICATION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED IN THE MANDARIN STUDY. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 190 CM3. 8.02 GBQ WAS ADMINISTERED THROUGH ONE VIAL. TOTAL ACTIVITY DELIVERED TO THE SUBJECT AT THE TIME OF TREATMENT WAS 2.48 GBQ. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.129 GBQ AND RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 600 GY. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. TARGET VOLUME WAS 123.3 CM3. 12.5 GBQ WAS ADMINISTERED THROUGH ONE VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.24 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 1.59 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 624 GY AND RADIATION DOSE TO LUNGS WAS 12 GY. ON (B)(6) 2024, 101 DAYS POST INDEX PROCEDURE AND THE SAME DAY OF RE-TREATMENT, THE SUBJECT EXPERIENCED ABDOMINAL PAIN AND NAUSEA. FLURBIPROFEN AXETIL INJECTION WAS GIVEN, AND COMPOUND CODEINE PHOSPHATE AND IBUPROFEN SUSTAINED RELEASE TABLETS WERE ADMINISTERED AS A CORRECTIVE ACTION FOR THE ABDOMINAL PAIN. ADDITIONALLY, MEDICATION WAS ADMINISTERED, OR REGIMEN WAS ADJUSTED TO TREAT THE NAUSEA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1998815 | THERASPHERE Y-90 (12.5 GBQ) CN CLINICAL | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LIMITED | 2361-01 | 2499456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |