This report combines information received between 28-dec-2017 and 29-jan-2018.This is the initial medical device report submitted to the fda.A serious adverse event report, (case number (b)(4)) was received on 28-dec-2017 from an investigator in (b)(4) regarding a male patient born in (b)(6) enrolled in "a prospective, multicentre, randomised, controlled study evaluating sir-spheres® y-90 resin microspheres preceding standard cisplatin-gemcitabine (cis-gem) chemotherapy versus cis-gem chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma (sircca)", study code (b)(4).The reported event term was dehydration.The patient's medical history was significant for unresectable intrahepatic cholangiocarcinoma, hyperparathyroidism, hypertension, liver pain and lower back pain, nausea, gastroesophageal reflux disease, stomach cramps, and anxiety.The patient was randomized in the combined treatment modality group of sir-spheres microspheres + cis-gem chemotherapy.Mapping procedure was performed on (b)(6) 2017.Implantation of sir-spheres microspheres (1.9 gbq, batch no.Lk211vi3) was performed on (b)(6) 2017 via right hepatic (1.35 gbq) and quadrate lope (0.45 gbq).At the time of the event, treatment with chemotherapy agents (cisplatin-gemcitabine) was not started.On (b)(6) 2017, the patient developed dehydration and was hospitalised for treatment with iv fluids (saline).The event was severe.Concomitant medication included: ostelin vit d (cholecalciferol): start date 2012 and ongoing, total daily dose 1 tablet, per oral, for hyperparathyroidism olmesartan hvt (40+12.5 mg) (olmesartan + hydrochlorothiazide): start date 2007 and ongoing, total daily dose 1 tablet, per oral, for hypertension targin 20/10 (oxycodone + naloxone): start date (b)(6) 2017 and ongoing, total daily dose 1 tablet, per oral, for liver pain and lower back pain metoclopramide (metoclopramide): start date (b)(6) 2017 and ongoing, total daily dose prn, tablet, per oral, for nausea pantoprazole (pantoprazole): start date 2015 and ongoing, total daily dose 40 mg, tablet, per oral, for gastroesophageal reflux disease buscopan forte (hyoscine butylbromide): hyoscine butylbromidehyoscine butylbromidestart date 2007 and ongoing, total daily dose 20 mg, tablet, per oral, for stomach cramps endone (oxycodone hydrochloride): start date (b)(6) 2017 and ongoing, total daily dose 5 mg, tablet, per oral, for liver pain and lower back pain diazepam (diazepam): start date (b)(6) 2017 and ongoing, total daily dose 20 mg, tablet, per oral, for anxiety pregabalin (pregabalin): start date (b)(6) 2017 and ongoing, total daily dose 100 mg, tablet, per oral, for lower back pain and liver pain ondansetron (ondansetron): start date (b)(6) 2017 to (b)(6) 2017, total daily dose prn, wafter, sublingual, for nausea.The reporter assessed all concomitant medications as not related to the sae.At the time of the report, the patient was recovering.Follow-up information was received on 12-jan-2018 and 16-jan-2018.Following sir-spheres microspheres, the patient had been affected by persistent nausea with poor oral intake, severe lethargy and decreased eastern cooperative oncology group (ecog) performance status.The patient had been dehydrated the week prior from (b)(6) 2017.The patient was not on cis-gem chemotherapy, he had indicated that he did not want to proceed with chemotherapy at the time of the event.The patient was treated with 2 litres of normal saline on (b)(6) 2017.The event stopped being serious on (b)(6) 2017.The outcome of dehydration was reported as recovered.The patient remained in hospital due to a separate sae (exacerbation of anxiety, linked case (b)(4)) until (b)(6) 2017 (discharge date from hospital).Follow-up information was received on 29-jan-2018.The investigator did not consider nausea, poor oral intake, severe lethargy, and decreased ecog performance status as separate saes since the admission was due to dehydration secondary to poor oral intake and lethargy.Reporter's comment: the investigator assessed the event as probably/likely related to sir-spheres microspheres (medical device) and as not related to the sir-spheres microspheres (mapping procedure) sir-spheres microspheres (implant procedure).
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