THERASPHERE Y-90 GLASS MICROSPHERES
Report
- Report Number
- 2134265-2021-08323
- Event Type
- Injury
- Date Received
- July 2, 2021
- Date of Event
- September 26, 2020
- Report Date
- November 2, 2023
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS EVENT WAS ORIGINAL REPORTED UNDER LEGACY BTG MFR REPORT #3002124543-2021-00014. THIS FOLLOW UP REPORT IS BEING SENT TO CAPTURE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED.
THIS EVENT WAS ORIGINAL REPORTED UNDER LEGACY BTG MFR REPORT #3002124543-2021-00014. THIS FOLLOW UP REPORT IS BEING SENT TO CAPTURE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. (B)(4).
IT WAS REPORTED THAT ABDOMINAL PAIN OCCURRED. IN (B)(6) 2020, SUBJECT (B)(6) SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTSV/VI/VII/VIII). 7.30 GBQ WAS ADMINISTERED TO THE LIVER (RIGHT LIVER) THROUGH VIAL 1. 9 DAYS POST TREATMENT WITH THERASPHERE, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN. IN (B)(6) 2020, 25 DAYS LATER, THE SUBJECT WAS HOSPITALIZED IN OTHER INSTITUTION FOR FURTHER EVALUATION AND TREATMENT. AS A TREATMENT, THE SUBJECT WAS PRESCRIBED WITH LOVENOX, OXYNORM BRO 5 MG AND INNOHEP 18000 U. 5 DAYS LATER, THE SUBJECT WAS DISCHARGED FROM HOSPITAL. IN (B)(6) 2020, 30 DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED. THIS EVENT WAS ORIGINAL REPORTED UNDER LEGACY BTG MFR REPORT #3002124543-2021-00014. THE FOLLOWING INFORMATION WAS RECEIVED AFTER THE INITIAL REPORT WAS SENT. ON (B)(6) 2020, 89 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT DEVELOPED ASCITES POSSIBLY DUE TO PROGRESSIVE DISEASE. THE EVENT WAS TREATED WITH PUNCTURE (3 TIMES) AND MEDICALLY TREATED WITH SPIRONOLACTONE 75 MG AND FUROSEMIDE 60 MG. THE PHYSICIAN NOTED THE EVENT TO BE NOT RELATED TO THE ADMINISTRATION PROCEDURE. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED NOT RECOVERED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT UPDATED THE ONSET FROM 15-DEC-2020 TO 25-NOV-2020 (69 DAYS) POST-THERASPHERE ADMINISTRATION. THE DOSES TO PERFUSED LIVER WAS 243.1 GY AND DOSE TO PERFUSED TUMOR WAS 262.1 GY.
IT WAS REPORTED THAT ABDOMINAL PAIN OCCURRED. IN (B)(6) 2020, SUBJECT (B)(6) SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTSV/VI/VII/VIII). 7.30 GBQ WAS ADMINISTERED TO THE LIVER (RIGHT LIVER) THROUGH VIAL 1. 9 DAYS POST TREATMENT WITH THERASPHERE, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN. IN (B)(6) 2020, 25 DAYS LATER, THE SUBJECT WAS HOSPITALIZED IN OTHER INSTITUTION FOR FURTHER EVALUATION AND TREATMENT. AS A TREATMENT, THE SUBJECT WAS PRESCRIBED WITH LOVENOX, OXYNORM BRO 5 MG AND INNOHEP 18000 U. 5 DAYS LATER, THE SUBJECT WAS DISCHARGED FROM HOSPITAL. IN (B)(6) 2020, 30 DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED. THIS EVENT WAS ORIGINAL REPORTED UNDER LEGACY BTG MFR REPORT #3002124543-2021-00014. THE FOLLOWING INFORMATION WAS RECEIVED AFTER THE INITIAL REPORT WAS SENT. ON (B)(6) 2020, 89 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT DEVELOPED ASCITES POSSIBLY DUE TO PROGRESSIVE DISEASE. THE EVENT WAS TREATED WITH PUNCTURE (3 TIMES) AND MEDICALLY TREATED WITH SPIRONOLACTONE 75 MG AND FUROSEMIDE 60 MG. THE PHYSICIAN NOTED THE EVENT TO BE NOT RELATED TO THE ADMINISTRATION PROCEDURE. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED NOT RECOVERED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT UPDATED THE ONSET FROM 15-DEC-2020 TO 25-NOV-2020 (69 DAYS) POST-THERASPHERE ADMINISTRATION. THE DOSES TO PERFUSED LIVER WAS 243.1 GY AND DOSE TO PERFUSED TUMOR WAS 262.1 GY. ADDITIONAL INFORMATION WAS AGAIN RECEIVED THAT CLARIFIED THE INITIAL PAIN WITH AN ONSET DATE OF 26-SEPT-2020 (9 DAYS POST-THERASPHERE TREATMENT). THE PAIN WAS FURTHER DESCRIBED AS ABDOMINAL PAIN RELATED TO AN EXTENSION OF PORTAL THROMBOSIS AND NOT ASCITES.
THIS EVENT WAS ORIGINAL REPORTED UNDER LEGACY BTG MFR REPORT #3002124543-2021-00014. THIS FOLLOW UP REPORT IS BEING SENT TO CAPTURE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED.
IT WAS REPORTED THAT ABDOMINAL PAIN OCCURRED. IN (B)(6) 2020, SUBJECT (B)(6) SUBJECT WAS ENROLLED INTO THE (B)(6) STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTSV/VI/VII/VIII). 7.30 GBQ WAS ADMINISTERED TO THE LIVER (RIGHT LIVER) THROUGH VIAL 1. 9 DAYS POST TREATMENT WITH THERASPHERE, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN. IN (B)(6) 2020, 25 DAYS LATER, THE SUBJECT WAS HOSPITALIZED IN OTHER INSTITUTION FOR FURTHER EVALUATION AND TREATMENT. AS A TREATMENT, THE SUBJECT WAS PRESCRIBED WITH LOVENOX, OXYNORM BRO 5 MG AND INNOHEP 18000 U. 5 DAYS LATER, THE SUBJECT WAS DISCHARGED FROM HOSPITAL. IN (B)(6) 2020, 30 DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED. THIS EVENT WAS ORIGINAL REPORTED UNDER LEGACY BTG MFR REPORT #3002124543-2021-00014. THE FOLLOWING INFORMATION WAS RECEIVED AFTER THE INITIAL REPORT WAS SENT. ON (B)(6) 2020, 89 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT DEVELOPED ASCITES POSSIBLY DUE TO PROGRESSIVE DISEASE. THE EVENT WAS TREATED WITH PUNCTURE (3 TIMES) AND MEDICALLY TREATED WITH SPIRONOLACTONE 75 MG AND FUROSEMIDE 60 MG. THE PHYSICIAN NOTED THE EVENT TO BE NOT RELATED TO THE ADMINISTRATION PROCEDURE. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED NOT RECOVERED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1008674 | THERASPHERE Y-90 GLASS MICROSPHERES | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Hospitalization| R |