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3 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to this serious adverse event.Refer to mdr 3002124543-2019-00007 and 3002124543-2019-00008 for the other device associated with this event.(b)(4).Subject: (b)(6).Last sae report: 12 feb 2019.Sae: cholecystitis.This report concerns subject (b)(6), a (b)(6) caucasian male subject, who was enrolled in study (b)(6) entitled (b)(6).On (b)(6) 2018, the subject was randomized to receive treatment with therasphere® for metastatic colorectal carcinoma and second-line chemotherapy (irinotecan).On (b)(6) 2018, the subject received the most recent cycle (first) of second-line chemotherapy, irinotecan 150 mg/m^2 intravenous (iv).On (b)(6) 2018, the subject received treatment with total 3 vials of therasphere®.The right hepatic lobe was treated with 2 vial (dose: 115.47 gy, activity of 15 gbq, lot no 1899474091 and 1899474092, expiry date: 26 oct 2018).One vial was administered in the left hepatic lobe (dose: 111.89 gy, vial activity of 15 gbq/lot no 1899474090, expiry date: 26 oct 2018).There is no relevant medical history to the event.Concomitant medications included alclometasone and lisinopril.On (b)(6) 2018, the subject complained of abdominal pain/cramping (grade 2), anorexia (grade 2), fatigue (grade 2) and vomiting (grade 1).As tylenol pm (acetaminophen and diphenhydramine) and ibuprofen pm (ibuprofen and diphenhydramine) were not relieving his symptoms, he was prescribed norco (hydrocodone and acetaminophen) 10/325mg.The subject started to improve and hence cycle 2 of irinotecan was administered on (b)(6) 2018.Post the irinotecan administration, on an unspecified date, the subject visited emergency department with complaints of abdominal pain and decreased bowel movements (bm).On (b)(6) 2018, ultrasound abdomen showed gallbladder wall thickening, which was nonspecific, there was sludge in the gallbladder and no shadowing stones were seen.There was no definite sono-graphic evidence of acute cholecystitis.Computerized tomogram (ct) of abdomen showed gallbladder wall thickening with surrounding pericholecystic fluid as well as adjacent thickening of the gastric antrum and proximal duodenum.There was no evidence of constipation.The subject was not hospitalized and was discharged with norco (hydrocodone and acetaminophen), prescribed zofran (ondansetron) and senna s (sennosides and docusate).On (b)(6) 2018, laboratory test showed alanine transaminase (alt) 77 unit/l (normal range: 12 -78); aspartate transaminase (ast) 60 unit/l (normal range: 15 -37) and alkaline phosphatase 215 unit/l (normal range: 46 -116).On (b)(6) 2018, oncologist added compazine (prochlorperazine) to the treatment regimen.Symptoms were milder with the medicines the subject was discharged with.Laboratory test showed albumin 3.2 g/dl (normal range: 3.4 - 5.0); alanine transaminase (alt) 84 unit/l (normal range: 12 -78); aspartate transaminase (ast) 53 unit/l (normal range: 15 -37) and alkaline phosphatase 218 unit/l (normal range: 46 -116).On (b)(6) 2018, the subject started on dexlansoprazole 30 mg daily, oral.On (b)(6) 2018, the subject received cycle 3 of irinotecan after 2 weeks delay due to these symptoms.Ct liver (triphasic) showed slight thickening of the gallbladder wall.It was reported that, since starting the dexlansoprazole the subject was eating better, putting weight on and was not vomiting.The subject still complained of gastrointestinal discomfort with eating and was not sleeping well due to the pain.The subject weaned off the norco (hydrocodone and acetaminophen) and started cbid (cannabidiol) oil and started to have bms again.Laboratory test showed albumin 3.1 g/dl (normal range: 3.4 - 5.0); alanine transaminase (alt) 202 unit/l (normal range: 12 -78); aspartate transaminase (ast) 149 unit/l (normal range: 15 -37) and alkaline phosphatase 275 unit/l (normal range: 46 -116).On (b)(6) 2018, the subject received cycle 4 of irinotecan and bevacizumab at normal dosing.The subject continued to have abdominal pain with digestion of food on but was much improved.His sleep was still affected.Laboratory test showed albumin 3.2 g/dl (normal range: 3.4 - 5.0); alanine transaminase (alt) 210 unit/l (normal range: 12 -78); aspartate transaminase (ast) 129 unit/l (normal range: 15 -37) and alkaline phosphatase 320 unit/l (normal range: 46 -116).On (b)(6) 2019, the subject received cycle 5 of irinotecan at decrease dose (150 mg/m^2 to 125 mg/m^2) and bevacizumab at normal dose (5 mg/m^2).The subject continued to have symptoms of grade 2 cholecystitis with some constipation.Laboratory test showed albumin 3.1 g/dl (normal range: 3.4 - 5.0); alanine transaminase (alt) 111 unit/l (normal range: 12 -78); aspartate transaminase (ast) 84 unit/l (normal range: 15 -37) and alkaline phosphatase 312 unit/l (normal range: 46 -116).On (b)(6) 2019, the subject underwent hida scan (cholescintigraphy and hepatobiliary scintigraphy) which showed a prompt concentration of the radio-pharmaceutical by the liver and activity within the duodenum and proximal small bowel at 10 minutes, indicating the common bile duct as patent.However, despite imaging out to nearly 4 hours, the gallbladder was never visualized.With the lack of significant symptoms, these changes probably are related to chronic cholecystitis.There was evidence of intermittent reflux of activity into the stomach which was of uncertain etiology or clinical significance.On (b)(6) 2019, laboratory test showed albumin 3.1 g/dl (normal range: 3.4 - 5.0); alanine transaminase (alt) 171 unit/l (normal range: 12 -78); aspartate transaminase (ast) 111 unit/l (normal range: 15 -37) and alkaline phosphatase 341 unit/l (normal range: 46 -116).On (b)(6) 2019, a cholecystostomy tube was inserted with drainage of normal appearing bile.On (b)(6) 2019, the subject recovered from the serious adverse event.The site has also reported that the subject was seen on (b)(6) 2018 and he didn't have any problems after eating.It was completely resolved since the drainage was placed on (b)(6) 2019.No antibiotics were given.The subject continued participation in the study.The investigator assessed the event of cholecystitis as grade-3 (severe) in intensity and serious due to other: procedure to be determined and definitely related to study device, unrelated to study procedure and to second line chemotherapy.The company agrees with the investigator's assessment.A supplemental report will be submitted if additional relevant information is received.
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