MAUDE Adverse Event Report: SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES

Lot Number LK211V13

Device Problem Insufficient Information (3190)

Patient Problem Dehydration (1807)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The adverse event of dehydration was classified as serious since it required hospitalization of a (b)(6) year-old male patient about four weeks after sir-spheres microspheres mapping procedure and about 3 weeks after sir-spheres implantation procedure.Dehydration is expected for sir-spheres microspheres but unexpected for mapping and implantation procedure.The temporal relationship is plausible for sir-spheres microspheres but implausible for both procedures.The patient received various concomitant drugs including oxycodone for which dehydration is a known side effect.Furthermore, the patient with underlying cholangiocarcinoma received treatment for nausea and stomach cramps which may have promoted a reduced fluid intake, however no further details on the event were reported.The investigator assessed the event of dehydration as probably/likely related to sir-spheres microspheres and as not related to implantation and mapping procedure.The sponsor assesses the causality as possibly related to sir-spheres microspheres and not related to implantation and mapping procedure.With follow-up information received on 12-jan-2018 and 16-jan-2018 information on event therapy and outcome (recovered) was provided.In addition, it was stated that the patient suffered from nausea, reduced oral intake, lethargy and reduced ecog performance status after sir-spheres microspheres implantation, which likely promoted development of dehydration and confirms the initial causality assessment: possibly related to sir-spheres microspheres and not related to implantation and mapping procedure.With follow-up information received on 29-jan-2018, it was clarified that only the event dehydration was considered serious and that dehydration developed secondary to reduced oral intake and lethargy.The sponsor's initial causality assessment remains unchanged.

Event Description

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).

• Brand Name: SIR-SPHERES® Y-90 RESIN MICROSPHERES
• Type of Device: MICROSPHERES
• Manufacturer (Section D): SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED; level 33; 101 miller street; north sydney, 2060 ; AS 2060
• Manufacturer Contact: level 33; 101 miller street; north sydney, 2060
• MDR Report Key: 7344854
• MDR Text Key: 102628331
• Report Number: 3005579300-2018-00004
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: LK211V13
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BUSCOPAN FORTE; DIAZEPAM; ENDONE; METOCLOPRAMIDE; OLMESARTAN HVT; ONDANSETRON; OSTELIN VIT D; PANTOPRAZOLE; PREGABALIN; TARGIN 20/10
• Patient Outcome(s): Hospitalization
• Patient Age: 53 YR
• Patient Weight: 87