THERASPHERE Y-90
Report
- Report Number
- 2124215-2025-27639
- Event Type
- Injury
- Date Received
- April 30, 2025
- Date of Event
- December 13, 2024
- Report Date
- May 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E2402 DENOTES THE SYMPTOM OF DISTENTION. D3, MANUFACTURER ZIP/POSTAL: (B)(6). G1, MFR SITE ZIP/POST CODE: (B)(6). BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION.
E2402 DENOTES THE SYMPTOM OF DISTENTION. D3, MANUFACTURER ZIP/POSTAL: GU9 8QL G1, MFR SITE ZIP/POST CODE: GU9 8QL THE UPN WAS NOT REPORTED FROM THE SITE; THUS, THE UDI REMAINS UNAVAILABLE.
E2402 DENOTES THE SYMPTOM OF DISTENTION. D3, MANUFACTURER ZIP/POSTAL: (B)(4), MFR SITE ZIP/POST CODE: (B)(4). BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION. INVESTIGATION RESULTS: LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A REVIEW OF THE THERASPHERE DEVICE CONFIRMED THAT THE REPORTED EVENT IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF 'KNOWN INHERENT RISK OF DEVICE.'
E2402 DENOTES THE SYMPTOM OF DISTENTION. D3, MANUFACTURER ZIP/POSTAL: GU9 8QL. G1, MFR SITE ZIP/POST CODE: GU9 8QL. BASED ON THE NATURE OF THIS PRODUCT, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) AND OTHER PRODUCT SPECIFIC INFORMATION.
IT WAS REPORTED THAT THIS SUBJECT WAS ADMITTED TO THE HOSPITAL (AND MEDICALLY TREATED) FOR ABDOMINAL DISTENSION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED TO (THERASPHERE ARM) IN THE CLINICAL STUDY (MAIN-IN PHASE) WITH THE PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. THE TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024; 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 81.45 CM3 WITH 3.81 GBQ ADMINISTERED THROUGH A SINGLE VIAL. THE TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.77 GBQ, THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 107.7 GY, AND TOTAL RADIATION DOSE TO LUNGS 3.9 GY AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS 411 GY. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT, AND THE TARGET VOLUME WAS 377.11CM3. A TOTAL OF 8.31 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.226 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE 3.19 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 411 GY AND RADIATION DOSE TO LUNGS WAS 11.3 GY. ON (B)(6) 2025, THE SUBJECT EXPERIENCED ABDOMINAL PAIN/DISTENSION AND WAS ADMITTED TO THE HOSPITAL. THE SUBJECT HAD NO CLEAR CAUSE OF UPPER ABDOMINAL DISCOMFORT AT HOME, EXPERIENCING INTERMITTENT DULL PAIN THAT WAS TOLERABLE. THEREFORE, TREATMENT HAD NOT BEEN ADMINISTERED. DURING THE PROGRESSION OF THE DISEASE, THE SUBJECT DID NOT SHOW ANY SYMPTOMS OF FEVER, CHILLS, NAUSEA, VOMITING, DIZZINESS, FATIGUE, PALPITATIONS, OR CHEST TIGHTNESS; HOWEVER, IT WAS NOTED THAT THE DISCOMFORT HAD INTENSIFIED OVER THE PAST WEEK. THE SUBJECT UNDERWENT COMPLETE BLOOD ROUTINE, BIOCHEMICAL, COAGULATION, TUMOR MARKERS, ELECTROCARDIOGRAM, AND IMAGING EXAMINATIONS. THE DIAGNOSIS RESULTS OF UPPER ABDOMEN REVEALED LIVER SEGMENT V LESIONS WERE REDUCED COMPARED TO BEFORE, AND THE EDGE ENHANCED NODULES WERE REDUCED COMPARED TO BEFORE. LIVER I, LAMP SEGMENT NODULES, AND LIVER V SEGMENT NODULES WAS INCREASED COMPARED TO BEFORE AND SHORT-TERM FOLLOW-UP WAS RECOMMENDED. CIRRHOSIS WITH MULTIPLE REGENERATIVE NODULES WAS CONSIDERED SIMILAR TO BEFORE HOWEVER SPLENOMEGALY AND ASCITES WAS INCREASED COMPARED TO BEFORE. MULTIPLE SMALL CYSTS IN THE LIVER AND SMALL CYSTS IN BOTH KIDNEYS WERE SIMILAR TO BEFORE. ON (B)(6) 2025, BLOOD ROUTINE EXAMINATIONS REVEALED THE FOLLOWING RESULTS: WHITE BLOOD CELL COUNT: 4.2 X 109/L, NEUTROPHIL PERCENTAGE: 76.6, LYMPHOCYTE PERCENTAGE: 8.3, RED BLOOD CELL COUNT: 3.77 X 1012/L, HEMOGLOBIN: 130 G/L, PLATELET COUNT: 186 X 109/L. COAGULATION FACTOR FOUR, D DIMER: PROTHROMBIN TIME: 13.7 SECONDS. DEXKETOPROFEN TROMETAMOL INJECTION (50MG/DAILY, (B)(6) 2025) WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE EVENT OF ABDOMINAL DISTENSION. ON (B)(6) 2025, THE SUBJECT CONDITION WAS EVALUATED AND WAS DISCHARGED ON THE SAME DAY. (B)(6) 2025, THE SUBJECT WAS HOSPITALIZED AND TREATED WITH LIVER PROTECTION THERAPIES, SPASMOLYTICS, PAIN RELIEF, FLUID REPLACEMENT, AND NUTRITIONAL SUPPORT. THE PATIENT HAD EXPERIENCED WEIGHT LOSS, WITH NO FURTHER ACTIONS TAKEN. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED IN OVERALL GOOD CONDITION; NO ABDOMINAL PAIN OR BLOATING, NO CHILLS OR FEVER, AND NO DISCOMFORT SUCH AS NAUSEA OR VOMITING. ADDITIONAL DETAILS WERE REPORTED THAT ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH NEUTROPHIL COUNT DECREASED. MEDICATION WAS ADMINISTERED AS A CORRECTIVE ACTION FOR TREATMENT.
IT WAS REPORTED THAT THIS SUBJECT WAS ADMITTED TO THE HOSPITAL (AND MEDICALLY TREATED) FOR ABDOMINAL DISTENSION. ON 09 -AUG-2024, THE SUBJECT WAS RANDOMIZED TO (THERASPHERE ARM) IN THE CLINICAL STUDY (MAIN-IN PHASE) WITH THE PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. THE TREATMENT WITH THERASPHERE WAS PERFORMED ON 21-AUG -2024; 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 81.45 CM3 WITH 3.81 GBQ ADMINISTERED THROUGH A SINGLE VIAL. THE TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.77 GBQ, THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 107.7 GY, AND TOTAL RADIATION DOSE TO LUNGS 3.9 GY AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS 411 GY. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON 12-DEC-2024. PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT, AND THE TARGET VOLUME WAS 377.11CM3. A TOTAL OF 8.31 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.226 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE 3.19 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 411 GY AND RADIATION DOSE TO LUNGS WAS 11.3 GY. ON 10-FEB-2025, THE SUBJECT EXPERIENCED ABDOMINAL PAIN/DISTENSION AND WAS ADMITTED TO THE HOSPITAL. THE SUBJECT HAD NO CLEAR CAUSE OF UPPER ABDOMINAL DISCOMFORT AT HOME, EXPERIENCING INTERMITTENT DULL PAIN THAT WAS TOLERABLE. THEREFORE, TREATMENT HAD NOT BEEN ADMINISTERED. DURING THE PROGRESSION OF THE DISEASE, THE SUBJECT DID NOT SHOW ANY SYMPTOMS OF FEVER, CHILLS, NAUSEA, VOMITING, DIZZINESS, FATIGUE, PALPITATIONS, OR CHEST TIGHTNESS; HOWEVER, IT WAS NOTED THAT THE DISCOMFORT HAD INTENSIFIED OVER THE PAST WEEK. THE SUBJECT UNDERWENT COMPLETE BLOOD ROUTINE, BIOCHEMICAL, COAGULATION, TUMOR MARKERS, ELECTROCARDIOGRAM, AND IMAGING EXAMINATIONS. THE DIAGNOSIS RESULTS OF UPPER ABDOMEN REVEALED LIVER SEGMENT V LESIONS WERE REDUCED COMPARED TO BEFORE, AND THE EDGE ENHANCED NODULES WERE REDUCED COMPARED TO BEFORE. LIVER I, LAMP SEGMENT NODULES, AND LIVER V SEGMENT NODULES WAS INCREASED COMPARED TO BEFORE AND SHORT-TERM FOLLOW-UP WAS RECOMMENDED. CIRRHOSIS WITH MULTIPLE REGENERATIVE NODULES WAS CONSIDERED SIMILAR TO BEFORE HOWEVER SPLENOMEGALY AND ASCITES WAS INCREASED COMPARED TO BEFORE. MULTIPLE SMALL CYSTS IN THE LIVER AND SMALL CYSTS IN BOTH KIDNEYS WERE SIMILAR TO BEFORE. ON 10-FEB-2025, BLOOD ROUTINE EXAMINATIONS REVEALED THE FOLLOWING RESULTS: WHITE BLOOD CELL COUNT: 4.2 X 109/L, NEUTROPHIL PERCENTAGE: 76.6, LYMPHOCYTE PERCENTAGE: 8.3, RED BLOOD CELL COUNT: 3.77 X 1012/L, HEMOGLOBIN: 130 G/L, PLATELET COUNT: 186 X 109/L. COAGULATION FACTOR FOUR, D DIMER: PROTHROMBIN TIME: 13.7 SECONDS. DEXKETOPROFEN TROMETAMOL INJECTION (50MG/DAILY, 10-FEB-2025- 13-FEB-2025) WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE EVENT OF ABDOMINAL DISTENSION. ON 13-FEB-2025, THE SUBJECT CONDITION WAS EVALUATED AND WAS DISCHARGED ON THE SAME DAY. ON 16-MAR-2025, THE SUBJECT WAS HOSPITALIZED AND TREATED WITH LIVER PROTECTION THERAPIES, SPASMOLYTICS, PAIN RELIEF, FLUID REPLACEMENT, AND NUTRITIONAL SUPPORT. THE PATIENT HAD EXPERIENCED WEIGHT LOSS, WITH NO FURTHER ACTIONS TAKEN. ON 24-MAR-2025, THE PATIENT WAS DISCHARGED IN OVERALL GOOD CONDITION; NO ABDOMINAL PAIN OR BLOATING, NO CHILLS OR FEVER, AND NO DISCOMFORT SUCH AS NAUSEA OR VOMITING.
IT WAS REPORTED THAT THIS SUBJECT WAS ADMITTED TO THE HOSPITAL (AND MEDICALLY TREATED) FOR ABDOMINAL DISTENSION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED TO (THERASPHERE ARM) IN THE CLINICAL STUDY (MAIN-IN PHASE) WITH THE PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. THE TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024; 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 81.45 CM3 WITH 3.81 GBQ ADMINISTERED THROUGH A SINGLE VIAL. THE TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.77 GBQ, THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 107.7 GY, AND TOTAL RADIATION DOSE TO LUNGS 3.9 GY AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS 411 GY. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT, AND THE TARGET VOLUME WAS 377.11CM3. A TOTAL OF 8.31 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.226 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE 3.19 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 411 GY AND RADIATION DOSE TO LUNGS WAS 11.3 GY. ON (B)(6) 2025, THE SUBJECT EXPERIENCED ABDOMINAL PAIN/DISTENSION AND WAS ADMITTED TO THE HOSPITAL. THE SUBJECT HAD NO CLEAR CAUSE OF UPPER ABDOMINAL DISCOMFORT AT HOME, EXPERIENCING INTERMITTENT DULL PAIN THAT WAS TOLERABLE. THEREFORE, TREATMENT HAD NOT BEEN ADMINISTERED. DURING THE PROGRESSION OF THE DISEASE, THE SUBJECT DID NOT SHOW ANY SYMPTOMS OF FEVER, CHILLS, NAUSEA, VOMITING, DIZZINESS, FATIGUE, PALPITATIONS, OR CHEST TIGHTNESS; HOWEVER, IT WAS NOTED THAT THE DISCOMFORT HAD INTENSIFIED OVER THE PAST WEEK. THE SUBJECT UNDERWENT COMPLETE BLOOD ROUTINE, BIOCHEMICAL, COAGULATION, TUMOR MARKERS, ELECTROCARDIOGRAM, AND IMAGING EXAMINATIONS. THE DIAGNOSIS RESULTS OF UPPER ABDOMEN REVEALED LIVER SEGMENT V LESIONS WERE REDUCED COMPARED TO BEFORE, AND THE EDGE ENHANCED NODULES WERE REDUCED COMPARED TO BEFORE. LIVER I, LAMP SEGMENT NODULES, AND LIVER V SEGMENT NODULES WAS INCREASED COMPARED TO BEFORE AND SHORT-TERM FOLLOW-UP WAS RECOMMENDED. CIRRHOSIS WITH MULTIPLE REGENERATIVE NODULES WAS CONSIDERED SIMILAR TO BEFORE HOWEVER SPLENOMEGALY AND ASCITES WAS INCREASED COMPARED TO BEFORE. MULTIPLE SMALL CYSTS IN THE LIVER AND SMALL CYSTS IN BOTH KIDNEYS WERE SIMILAR TO BEFORE. ON (B)(6) 2025, BLOOD ROUTINE EXAMINATIONS REVEALED THE FOLLOWING RESULTS: WHITE BLOOD CELL COUNT: 4.2 X 109/L, NEUTROPHIL PERCENTAGE: 76.6, LYMPHOCYTE PERCENTAGE: 8.3, RED BLOOD CELL COUNT: 3.77 X 1012/L, HEMOGLOBIN: 130 G/L, PLATELET COUNT: 186 X 109/L. COAGULATION FACTOR FOUR, D DIMER: PROTHROMBIN TIME: 13.7 SECONDS. DEXKETOPROFEN TROMETAMOL INJECTION (50MG/DAILY, (B)(6) 2025) WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE EVENT OF ABDOMINAL DISTENSION. ON (B)(6) 2025, THE SUBJECT CONDITION WAS EVALUATED AND WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2025, THE SUBJECT WAS HOSPITALIZED AND TREATED WITH LIVER PROTECTION THERAPIES, SPASMOLYTICS, PAIN RELIEF, FLUID REPLACEMENT, AND NUTRITIONAL SUPPORT. THE PATIENT HAD EXPERIENCED WEIGHT LOSS, WITH NO FURTHER ACTIONS TAKEN. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED IN OVERALL GOOD CONDITION; NO ABDOMINAL PAIN OR BLOATING, NO CHILLS OR FEVER, AND NO DISCOMFORT SUCH AS NAUSEA OR VOMITING. ADDITIONAL DETAILS WERE REPORTED THAT ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH NEUTROPHIL COUNT DECREASED. MEDICATION WAS ADMINISTERED AS A CORRECTIVE ACTION FOR TREATMENT. ADDITIONAL DETAILS PROVIDED THAT MRI FINDINGS INDICATED LIVER CIRRHOSIS AND ASCITES. THE SUBJECT RECEIVED APPROPRIATE PAIN/SPASM RELIEF AND LIVER PROTECTION TREATMENT.
IT WAS REPORTED THAT THIS SUBJECT WAS ADMITTED TO THE HOSPITAL (AND MEDICALLY TREATED) FOR ABDOMINAL DISTENSION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED TO (THERASPHERE ARM) IN THE CLINICAL STUDY (MAIN-IN PHASE) WITH THE PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. THE TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024; 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 81.45 CM3 WITH 3.81 GBQ ADMINISTERED THROUGH A SINGLE VIAL. THE TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.77 GBQ, THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 107.7 GY, AND TOTAL RADIATION DOSE TO LUNGS 3.9 GY AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS 411 GY. RE-TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT, AND THE TARGET VOLUME WAS 377.11CM3. A TOTAL OF 8.31 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.226 GBQ AND TOTAL ACTIVITY OF THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE 3.19 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 411 GY AND RADIATION DOSE TO LUNGS WAS 11.3 GY. ON (B)(6) 2025, THE SUBJECT EXPERIENCED ABDOMINAL PAIN/DISTENSION AND WAS ADMITTED TO THE HOSPITAL. THE SUBJECT HAD NO CLEAR CAUSE OF UPPER ABDOMINAL DISCOMFORT AT HOME, EXPERIENCING INTERMITTENT DULL PAIN THAT WAS TOLERABLE. THEREFORE, TREATMENT HAD NOT BEEN ADMINISTERED. DURING THE PROGRESSION OF THE DISEASE, THE SUBJECT DID NOT SHOW ANY SYMPTOMS OF FEVER, CHILLS, NAUSEA, VOMITING, DIZZINESS, FATIGUE, PALPITATIONS, OR CHEST TIGHTNESS; HOWEVER, IT WAS NOTED THAT THE DISCOMFORT HAD INTENSIFIED OVER THE PAST WEEK. THE SUBJECT UNDERWENT COMPLETE BLOOD ROUTINE, BIOCHEMICAL, COAGULATION, TUMOR MARKERS, ELECTROCARDIOGRAM, AND IMAGING EXAMINATIONS. THE DIAGNOSIS RESULTS OF UPPER ABDOMEN REVEALED LIVER SEGMENT V LESIONS WERE REDUCED COMPARED TO BEFORE, AND THE EDGE ENHANCED NODULES WERE REDUCED COMPARED TO BEFORE. LIVER I, LAMP SEGMENT NODULES, AND LIVER V SEGMENT NODULES WAS INCREASED COMPARED TO BEFORE AND SHORT-TERM FOLLOW-UP WAS RECOMMENDED. CIRRHOSIS WITH MULTIPLE REGENERATIVE NODULES WAS CONSIDERED SIMILAR TO BEFORE HOWEVER SPLENOMEGALY AND ASCITES WAS INCREASED COMPARED TO BEFORE. MULTIPLE SMALL CYSTS IN THE LIVER AND SMALL CYSTS IN BOTH KIDNEYS WERE SIMILAR TO BEFORE. ON (B)(6) 2025, BLOOD ROUTINE EXAMINATIONS REVEALED THE FOLLOWING RESULTS: WHITE BLOOD CELL COUNT: 4.2 X 109/L, NEUTROPHIL PERCENTAGE: 76.6, LYMPHOCYTE PERCENTAGE: 8.3, RED BLOOD CELL COUNT: 3.77 X 1012/L, HEMOGLOBIN: 130 G/L, PLATELET COUNT: 186 X 109/L. COAGULATION FACTOR FOUR, D DIMER: PROTHROMBIN TIME: 13.7 SECONDS. DEXKETOPROFEN TROMETAMOL INJECTION (50MG/DAILY, (B)(6) 2025) WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE EVENT OF ABDOMINAL DISTENSION. ON (B)(6) 2025, THE SUBJECT CONDITION WAS EVALUATED AND WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2025, THE SUBJECT WAS HOSPITALIZED AND TREATED WITH LIVER PROTECTION THERAPIES, SPASMOLYTICS, PAIN RELIEF, FLUID REPLACEMENT, AND NUTRITIONAL SUPPORT. THE PATIENT HAD EXPERIENCED WEIGHT LOSS, WITH NO FURTHER ACTIONS TAKEN. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED IN OVERALL GOOD CONDITION; NO ABDOMINAL PAIN OR BLOATING, NO CHILLS OR FEVER, AND NO DISCOMFORT SUCH AS NAUSEA OR VOMITING. ADDITIONAL DETAILS WERE REPORTED THAT ON (B)(6) 2024, THE SUBJECT WAS NOTED WITH NEUTROPHIL COUNT DECREASED. MEDICATION WAS ADMINISTERED AS A CORRECTIVE ACTION FOR TREATMENT. ADDITIONAL DETAILS PROVIDED THAT MRI FINDINGS INDICATED LIVER CIRRHOSIS AND ASCITES. THE SUBJECT RECEIVED APPROPRIATE PAIN/SPASM RELIEF AND LIVER PROTECTION TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227909 | THERASPHERE Y-90 | MICROSPHERES RADIONUCLIDE | NAW | BOSTON SCIENTIFIC CORPORATION | 2499582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |