THERASPHERE Y-90
Report
- Report Number
- 2124215-2024-84127
- Event Type
- Injury
- Date Received
- January 16, 2025
- Date of Event
- December 27, 2022
- Report Date
- April 11, 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, MANUFACTURER ZIP/POSTAL: (B)(6). G1, MFR SITE ZIP/POST CODE: (B)(6).
D3, MANUFACTURER ZIP/POSTAL: (B)(6), G1, MFR SITE ZIP/POST CODE: (B)(6).
THIS CORRECTION REPORT IS BEING SENT TO UPDATE THE D6A: IMPLANT DATE. D3, MANUFACTURER ZIP/POSTAL: GU9 8QL G1, MFR SITE ZIP/POST CODE: GU9 8QL
IT WAS REPORTED THAT THE SUBJECT EXPERIENCED REFRACTORY ASCITES. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO A CLINICAL STUDY AND THE TREATMENT WITH THERASPHERE Y-90 GLASS MICROSPHERES WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS SELECTIVE. ON (B)(6) 2022, 153 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS ADMITTED IN THE HOSPITAL DUE TO RECENT INCREASE IN ASCITES AND WAS THE DIAGNOSED WITH REFRACTORY ASCITES. REGULAR ASCITES PUNCTURE WAS PERFORMED AS A CORRECTIVE ACTION TO TREAT THE EVENT. THE DIURETIC TREATMENT WAS DIFFICULT TO INSTITUTE TO THE PATIENT DUE TO DETERIORATING RENAL FUNCTION. THEREFORE, MONTHLY ASCITES PUNCTURES WERE PLANNED SINCE (B)(6) 2022. THE LAST ASCITES PUNCTURE WAS PERFORMED IN (B)(6) 2023 AND THE EVENT WAS CONSIDERED RESOLVED. ADDITIONAL DETAILS WERE PROVIDED REGARDING THE ADMINISTRATION. VASCULAR ACCESS WAS THROUGH FEMORAL ARTERY WHERE 3.255 GBQ WAS ADMINISTERED TO THE SELECTIVE LIVER USING A SINGLE VIAL.
THE SUBJECT WAS ENROLLED IN THE PROACTIF CLINICAL STUDY WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THE SUBJECT EXPERIENCED REFRACTORY ASCITES. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. ON (B)(6)2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF CLINICAL STUDY AND THE TREATMENT WITH THERASPHERE Y-90 GLASS MICROSPHERES WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS SELECTIVE. ON (B)(6) 2022, 153 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS ADMITTED IN THE HOSPITAL DUE TO RECENT INCREASE IN ASCITES AND WAS THE DIAGNOSED WITH REFRACTORY ASCITES. REGULAR ASCITES PUNCTURE WAS PERFORMED AS A CORRECTIVE ACTION TO TREAT THE EVENT. THE DIURETIC TREATMENT WAS DIFFICULT TO INSTITUTE TO THE PATIENT DUE TO DETERIORATING RENAL FUNCTION. THEREFORE, MONTHLY ASCITES PUNCTURES WERE PLANNED SINCE (B)(6) 2022. THE LAST ASCITES PUNCTURE WAS PERFORMED IN (B)(6) 2023 AND THE EVENT WAS CONSIDERED RESOLVED.
THE SUBJECT WAS ENROLLED IN THE PROACTIF CLINICAL STUDY WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THE SUBJECT EXPERIENCED REFRACTORY ASCITES. THE SUBJECT WAS HOSPITALIZED, AND INTERVENTION WAS PERFORMED AS A RESULT. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF CLINICAL STUDY AND THE TREATMENT WITH THERASPHERE Y-90 GLASS MICROSPHERES WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS SELECTIVE. ON (B)(6) 2022, 153 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS ADMITTED IN THE HOSPITAL DUE TO RECENT INCREASE IN ASCITES AND WAS THE DIAGNOSED WITH REFRACTORY ASCITES. REGULAR ASCITES PUNCTURE WAS PERFORMED AS A CORRECTIVE ACTION TO TREAT THE EVENT. THE DIURETIC TREATMENT WAS DIFFICULT TO INSTITUTE TO THE PATIENT DUE TO DETERIORATING RENAL FUNCTION. THEREFORE, MONTHLY ASCITES PUNCTURES WERE PLANNED SINCE (B)(6) 2022. THE LAST ASCITES PUNCTURE WAS PERFORMED IN (B)(6) 2023 AND THE EVENT WAS CONSIDERED RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1253284 | THERASPHERE Y-90 | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | Hospitalization| R |