Y-90 THERASPHERE (3 GBQ) CANADA COMM
Report
- Report Number
- 2124215-2024-73857
- Event Type
- Injury
- Date Received
- November 27, 2024
- Date of Event
- October 24, 2024
- Report Date
- May 14, 2025
- Manufacturer
- BIOCOMPATIBLES UK LIMITED
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPDATED FIELDS: A1 - PATIENT IDENTIFIER. B5 - DESCRIBE EVENT OR PROBLEM. D3 - MANUFACTURER ADDRESS 1, MANUFACTURER ADDRESS 2, MANUFACTURER ZIP/POSTAL CODE. G1 - MFR SITE ADDRESS 1, MFR SITE ADDRESS 2, MFR SITE ZIP/POST CODE. A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 64 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. A4 - WEIGHT: 84.30 KG.
A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 64 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. A4 - WEIGHT: 84.30 KG D3 & G1 - MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: GU9 8QL.
UPDATED FIELDS: B5 - DESCRIBE EVENT OR PROBLEM. A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 64 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. A4 - WEIGHT: 84.30 KG. BASED ON THE NATURE OF THE PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE SUBJECT EXPERIENCED AN ESOPHAGEAL VARICES HEMORRHAGE. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6)2024. PRETREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS (B)(4). ON (B)(6)2024, THERASPHERE TREATMENT WAS PERFORMED. ONE DOSE VIAL WAS ADMINISTERED THROUGH THE FEMORAL ARTERY. ON (B)(6)2024, 83 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLACK STOOLS AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY WITH THE CONCERNS OF ESOPHAGEAL VARICES HEMORRHAGE. ON THE SAME DAY, HEMOGLOBIN WAS 13.7. ESOPHAGOGASTRODUODENOSCOPY NOTED A SINGLE OF GRADE III ESOPHAGEAL NONBLEEDING VARIX WITH RED WALE SIGN STATUS POST BANDING X1 WITH COMPLETE ERADICATION. ANOTHER GRADE II VARIX WITHOUT HIGH-RISK FEATURES WAS OBSERVED. LOS ANGELES (LA) GRADE A ESOPHAGITIS, AND DIFFUSE HYPERTENSIVE GASTROPATHY WERE ALSO NOTED. THE EVENT WAS TREATED WITH PANTOPRAZOLE (PROTONIX) (40MG/TWICE DAILY, (B)(6)2024- ONGOING) AND SULFAMETHOXAZOLE-TRIMETHOPRIM (BACTRIM DS) (800-160MG PER TABLET/TWICE DAILY, (B)(6)2024). NO ACTION WAS TAKEN WITH REGARDS TO THE STUDY TREATMENT AND STUDY MEDICATIONS. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2024. IT WAS FURTHER REPORTED THAT THE TOTAL THERASPHERE ACTIVITY ADMINISTERED ACTIVITY WAS 2.18GBQ.
ROWAN CLINICAL TRIAL IT WAS REPORTED THAT THE SUBJECT EXPERIENCED AN ESOPHAGEAL VARICES HEMORRHAGE. THE SUBJECT WAS ENROLLED INTO THE ROWAN STUDY ON (B)(6) 2024. PRETREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.3 %. ON (B)(6) 2024, THERASPHERE TREATMENT WAS PERFORMED. ONE DOSE VIAL WAS ADMINISTERED THROUGH THE FEMORAL ARTERY. ON (B)(6) 2024, 83 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLACK STOOLS AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY WITH THE CONCERNS OF ESOPHAGEAL VARICES HEMORRHAGE. ON THE SAME DAY, HEMOGLOBIN WAS 13.7. ESOPHAGOGASTRODUODENOSCOPY NOTED A SINGLE OF GRADE III ESOPHAGEAL NONBLEEDING VARIX WITH RED WALE SIGN STATUS POST BANDING X1 WITH COMPLETE ERADICATION. ANOTHER GRADE II VARIX WITHOUT HIGH-RISK FEATURES WAS OBSERVED. LOS ANGELES (LA) GRADE A ESOPHAGITIS, AND DIFFUSE HYPERTENSIVE GASTROPATHY WERE ALSO NOTED. THE EVENT WAS TREATED WITH PANTOPRAZOLE (PROTONIX) (40MG/TWICE DAILY, (B)(6) 2024- ONGOING) AND SULFAMETHOXAZOLE-TRIMETHOPRIM (BACTRIM DS) (800-160MG PER TABLET/TWICE DAILY, (B)(6) 2024). NO ACTION WAS TAKEN WITH REGARDS TO THE STUDY TREATMENT AND STUDY MEDICATIONS. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024.
IT WAS REPORTED THAT THE SUBJECT EXPERIENCED AN ESOPHAGEAL VARICES HEMORRHAGE. THE SUBJECT WAS ENROLLED INTO THE STUDY ON (B)(6) 2024. PRETREATMENT MAA IMAGING DOCUMENTED A SIGNIFICANTLY HIGHER PERFUSION OF MAA ON TUMORS. LUNG SHUNT CALCULATION WAS 0.3 %. ON (B)(6) 2024, THERASPHERE TREATMENT WAS PERFORMED. ONE DOSE VIAL WAS ADMINISTERED THROUGH THE FEMORAL ARTERY. ON (B)(6) 2024, 83 DAYS POST THERASPHERE ADMINISTRATION, THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF BLACK STOOLS AND WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY WITH THE CONCERNS OF ESOPHAGEAL VARICES HEMORRHAGE. ON THE SAME DAY, HEMOGLOBIN WAS 13.7. ESOPHAGOGASTRODUODENOSCOPY NOTED A SINGLE OF GRADE III ESOPHAGEAL NONBLEEDING VARIX WITH RED WALE SIGN STATUS POST BANDING X1 WITH COMPLETE ERADICATION. ANOTHER GRADE II VARIX WITHOUT HIGH-RISK FEATURES WAS OBSERVED. LOS ANGELES (LA) GRADE A ESOPHAGITIS, AND DIFFUSE HYPERTENSIVE GASTROPATHY WERE ALSO NOTED. THE EVENT WAS TREATED WITH PANTOPRAZOLE (PROTONIX) (40MG/TWICE DAILY, (B)(6) 2024- ONGOING) AND SULFAMETHOXAZOLE-TRIMETHOPRIM (BACTRIM DS) (800-160MG PER TABLET/TWICE DAILY, (B)(6) 2024). NO ACTION WAS TAKEN WITH REGARDS TO THE STUDY TREATMENT AND STUDY MEDICATIONS. THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE TOTAL THERASPHERE ACTIVITY ADMINISTERED ACTIVITY WAS 2.18GBQ. IT WAS FURTHER REPORTED THAT TWO DOSE VIALS WERE ADMINISTERED DURING THE INDEX PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2357404 | Y-90 THERASPHERE (3 GBQ) CANADA COMM | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R |