Y-90 THERASPHERE
Report
- Report Number
- 2124215-2024-53348
- Event Type
- Death
- Date Received
- September 4, 2024
- Date of Event
- February 19, 2024
- Report Date
- December 19, 2024
- Manufacturer
- BIOCOMPATIBLES UK LIMITED
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION A2: DATE OF BIRTH: ON (B)(6) 1948. D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PAR.K G1: MFR SITE ZIP/POST CODE: GU9 8QL.
A2: DATE OF BIRTH: (B)(6) 1948. D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3: MANUFACTURER ZIP/POSTAL CODE: (B)(6). G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK G1: MFR SITE ZIP/POST CODE: (B)(6).
B5 DESCRIBE EVENT OR PROBLEM: UPDATED WITH ADDITIONAL INFORMATION. H6 PATIENT CODES: REMOVED E0313 BLOOD PROTEIN ABNORMAL A2: DATE OF BIRTH: (B)(6) 1948. D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ZIP/POST CODE: GU9 8QL.
PROACTIF CLINICAL STUDY. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED DOSE TO TOTAL PERFUSED LIVER AS 552 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 627 GY. ON (B)(6) 2024, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS LEFT LIVER. THE CATHETER WAS POSITIONED AT LEFT LATERAL SECTOR (SEGMENTS II/III). 3.93 GBQ WAS ADMINISTERED TO THE LEFT LIVER THROUGH VIAL 1. ON (B)(6) 2024, 28 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HEPATIC ENCEPHALOPATHY. DURING THIS TIME, NO ACTION WAS TAKEN. ON (B)(6) 2024, 47 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS ADMITTED TO THE HOSPITAL. DURING THIS HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH A LUNG INFECTION. SUBJECT HAD HEPATIC ENCEPHALOPATHY WITH IMPAIRED CONSCIOUSNESS. HOWEVER, NO ASTERIXIS WAS NOTED. THE SUBJECT WAS VERY SLEEPY AND COMATOSE. ASCITES WAS MODERATE TO ABSENT. CLINICAL EVALUATIONS REVEALED ALBUMIN: 22G/L, TP: 42%, ASCITES:2, ENCEPHALOPATHY: 3, AMMONEMIA: 73 MMOL/L. TRIPLEX PCR WAS NEGATIVE, AND CHEST X-RAY WAS PERFORMED WHICH SHOWED POSSIBLE LEFT LOWER LOBAR FOCUS FOR THE LUNG INFECTION. ACUTE COMMUNITY-ACQUIRED PNEUMONIA COMPLICATED BY ACUTE RESPIRATORY FAILURE AND SEPSIS WITH CONSCIOUSNESS DISTURBANCES AND HYPOTENSION. MEDICATION INCLUDING LACTULOSE WAS ADMINISTERED TO TREAT THE HEPATIC ENCEPHALOPATHY. CEFOTAXIME, SPIRAMYCIN WERE ADMINISTRATED FOR 3 DAYS AND CEFTRIAXONE FOR ONE DAY TREAT THE LUNG INFECTION. ON (B)(6) 2024, 48 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HYPOALBUMINEIA, AND MEDICATION WAS ADMINISTERED TO TREAT. ON (B)(6) 2024, SPO2 86% IN AMBIENT AIR WAS MAINTAINED. HOWEVER, LATER THE SUBJECT LAPSED INTO PERMANENT COMA. ON (B)(6) 2024, 52 DAYS POST INDEX PROCEDURE, THE SUBJECT PASSED AWAY DUE TO LIVER FUNCTION DETERIORATION. IT WAS FURTHER REPORTED THAT HYPOALBUMINEIA WAS NOT RELATED TO THE THERASPHERE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE PER THE INVESTIGATOR. ADDITIONALLY, CONCOMITANT MEDICATION WAS GIVEN TO TREAT HEPATIC ENCEPHALOPATHY ON (B)(6) 2024.
PROACTIF CLINICAL STUDY IT WAS REPORTED THAT PATIENT DEATH OCCURRED. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED DOSE TO TOTAL PERFUSED LIVER AS 552 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 627 GY. ON (B)(6) 2024, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS LEFT LIVER. THE CATHETER WAS POSITIONED AT LEFT LATERAL SECTOR (SEGMENTS II/III). 3.93 GBQ WAS ADMINISTERED TO THE LEFT LIVER THROUGH VIAL 1. ON (B)(6) 2024, 28 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HEPATIC ENCEPHALOPATHY. DURING THIS TIME, NO ACTION WAS TAKEN. ON (B)(6) 2024, 47 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS ADMITTED TO THE HOSPITAL. DURING THIS HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH A LUNG INFECTION. SUBJECT HAD HEPATIC ENCEPHALOPATHY WITH IMPAIRED CONSCIOUSNESS. HOWEVER, NO ASTERIXIS WAS NOTED. THE SUBJECT WAS VERY SLEEPY AND COMATOSE. ASCITES WAS MODERATE TO ABSENT. CLINICAL EVALUATIONS REVEALED ALBUMIN: 22G/L, TP: 42%, ASCITES:2, ENCEPHALOPATHY: 3, AMMONEMIA: 73 MMOL/L. TRIPLEX PCR WAS NEGATIVE, AND CHEST X-RAY WAS PERFORMED WHICH SHOWED POSSIBLE LEFT LOWER LOBAR FOCUS FOR THE LUNG INFECTION. ACUTE COMMUNITY-ACQUIRED PNEUMONIA COMPLICATED BY ACUTE RESPIRATORY FAILURE AND SEPSIS WITH CONSCIOUSNESS DISTURBANCES AND HYPOTENSION. MEDICATION INCLUDING LACTULOSE WAS ADMINISTERED TO TREAT THE HEPATIC ENCEPHALOPATHY. CEFOTAXIME, SPIRAMYCIN WERE ADMINISTRATED FOR 3 DAYS AND CEFTRIAXONE FOR ONE DAY TREAT THE LUNG INFECTION. ON (B)(6) 2024, 48 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HYPOALBUMINEIA, AND MEDICATION WAS ADMINISTERED TO TREAT. ON (B)(6) 2024, SPO2 86% IN AMBIENT AIR WAS MAINTAINED. HOWEVER, LATER THE SUBJECT LAPSED INTO PERMANENT COMA. ON (B)(6) 2024, 52 DAYS POST INDEX PROCEDURE, THE SUBJECT PASSED AWAY DUE TO LIVER FUNCTION DETERIORATION.
PROACTIF CLINICAL STUDY. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. ADVANCED, MULTICOMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACROAGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED DOSE TO TOTAL PERFUSED LIVER AS 552 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 627 GY. ON (B)(6) 2024, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS LEFT LIVER. THE CATHETER WAS POSITIONED AT LEFT LATERAL SECTOR (SEGMENTS II/III). 3.93 GBQ WAS ADMINISTERED TO THE LEFT LIVER THROUGH VIAL 1. ON (B)(6) 2024, 28 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HEPATIC ENCEPHALOPATHY. DURING THIS TIME, NO ACTION WAS TAKEN. ON (B)(6) 2024, 47 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS ADMITTED TO THE HOSPITAL. DURING THIS HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH A LUNG INFECTION. SUBJECT HAD HEPATIC ENCEPHALOPATHY WITH IMPAIRED CONSCIOUSNESS. HOWEVER, NO ASTERIXIS WAS NOTED. THE SUBJECT WAS VERY SLEEPY AND COMATOSE. ASCITES WAS MODERATE TO ABSENT. CLINICAL EVALUATIONS REVEALED ALBUMIN: 22G/L, TP: 42%, ASCITES:2, ENCEPHALOPATHY: 3, AMMONEMIA: 73 MMOL/L. TRIPLEX PCR WAS NEGATIVE, AND CHEST X-RAY WAS PERFORMED WHICH SHOWED POSSIBLE LEFT LOWER LOBAR FOCUS FOR THE LUNG INFECTION. ACUTE COMMUNITY-ACQUIRED PNEUMONIA COMPLICATED BY ACUTE RESPIRATORY FAILURE AND SEPSIS WITH CONSCIOUSNESS DISTURBANCES AND HYPOTENSION. MEDICATION INCLUDING LACTULOSE WAS ADMINISTERED TO TREAT THE HEPATIC ENCEPHALOPATHY. CEFOTAXIME, SPIRAMYCIN WERE ADMINISTRATED FOR 3 DAYS AND CEFTRIAXONE FOR ONE DAY TREAT THE LUNG INFECTION. ON (B)(6) 2024, 48 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH HYPOALBUMINEMIA, AND MEDICATION WAS ADMINISTERED TO TREAT. ON (B)(6) 2024, SPO2 86% IN AMBIENT AIR WAS MAINTAINED. HOWEVER, LATER THE SUBJECT LAPSED INTO PERMANENT COMA. ON (B)(6) 2024, 52 DAYS POST INDEX PROCEDURE, THE SUBJECT PASSED AWAY DUE TO LIVER FUNCTION DETERIORATION. IT WAS FURTHER REPORTED THAT HYPOALBUMINEMIA WAS NOT RELATED TO THE THERASPHERE DEVICE BUT POSSIBLY RELATED TO THE PROCEDURE PER THE INVESTIGATOR. ADDITIONALLY, CONCOMITANT MEDICATION WAS GIVEN TO TREAT HEPATIC ENCEPHALOPATHY ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT HYPOALBUMINEMIA WAS NOT RELATED TO THE THERASPHERE PROCEDURE PER THE INVESTIGATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1386058 | Y-90 THERASPHERE | MICROSPHERES RADIONUCLIDE | NAW | BIOCOMPATIBLES UK LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Death |