MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Encephalopathy (1833)

Event Date 02/03/2020

Event Type  Death  

Manufacturer Narrative

Btg medical assessment: patient: (b)(6) year old, male medical history: no known allergies.Never smoker.No alcohol use.No substance abuse.Heavy comorbidities: altered mental status, obesity (bmi=45.0-39.9), tia, congestive heart failure, hypertension, bronchitis, benign prostatic hypertrophy, arthritis, osteoarthritis and depression, dysphagia, prior patient liver disease history= hepatocellular carcinoma, acute encephalopathy, hepatic cirrhosis associated with hemochromatosis, dementia, developmental delay, /thrombocytopenia, case description patient received atheraspheres treatment on (b)(6) 2020 without complications.Unknown, tumor location, activity administered, volume of liver treated, volume of remnant liver, presence of ascites, liver function test at baseline 15 days later ((b)(6) 2020), mri-abdomen/pelvis completed.Result of the mri unknown.20-21 days later ((b)(6) 2020) patient reports pain in right side of his abdomen.Unknown what treatment was provided two-three days later on (b)(6) 2020 patient went to local hospital er and was admitted hospital.Medical history/medication review/physical exam/vitals/review of systems, ct-abdomen and pelvis and clinical labs were obtained with initial upper quadrant abdominal pain, liver masses diagnosis, condition=stable.(b)(6) 2020= mri-abdomen obtained and reviewed with continued right upper quadrant pain.(b)(6) 2020= chest x-ray was obtained and reviewed with continued right upper quadrant pain.Patient did not want to return to columbus, oh for care, so stayed at cambridge, oh hospital and obtained medical records for review.(b)(6) 2020= palliative care consult was ordered and reviewed with continued abdominal pain.(b)(6) 2020= continued review of systems, but patient becoming less responsive, so comfort care, end of life decisions, symptom management reviewed, code status changed to dnrcc and hospice was arranged to cambridge care & rehab and hospice of guernsey.(b)(6) 2020= review of systems, chest x-ray, palliative care and continued to be less responsive.Hospice transfer planned for tomorrow.(b)(6) 2020= cont.Palliative care and recommend keeping him to avoid potential death en route to hospice.Patient passed away 9:30pm." relevant tests: no results seen.Ct-abdomen and pelvis (b)(6) 2020.Mri abdomen (b)(6) 2020.Chest x-ray (b)(6) 2020.Chest x-ray (b)(6) 2020.Cbc with electronic differential labs (b)(6) 2020.Complete metabolic panel labs (b)(6) 2020.Afp tumor marker (b)(6) 2020.Afp tumor marker (b)(6) 2020.Daily clinical labs/reviews of systems/vitals/medication review completed during southeastern med, cambridge, oh hospitalization from (b)(6) 2020-(b)(6) 2020.Concomitant therapy: y-90-therasphere therapy date= (b)(6) 2020.Concomitant meds on (b)(6) 2020, that are daily medical treatment of the patient: atorvastatin 40 mg tab tablet; spironolactone 100 mg tab tablet; lactulose 10 gm/15ml solution oral solution and supportive treatment for the administration of therasphere: = sodium chloride sodium chloride 0.9%, iv solution, 300ml/hr; midazolam hcl (pf)(versed) iv injection, 0.5mg x4; lidocaine (pf) 2% subcutaneous injection 2ml, once; iohexol (omnipaque), 300mg/ml, 45ml once, iv injection; fentanyl (sublimaze) iv injection, 25mcg x4.Group home meds: omeprazole 20 mg cap dr capsule; aspirin 81 mg chew tab chewable tablet; my conclusion is that the patient presented with pain and alteration of vigilance, (encephalopathy) it is mentioned in the patient medical history that acute encephalopathy had occurred.The information provided by the site are not so informative to document what was the cause of the event no element for disease progression, ascites, bleeding, infection was reported.Abdominal pain and vigilance alteration that led to death one months after the administration of therasphere there was no device failure or malfunction abdominal pain: severity 3; causality - likely device; ;serious - led to hospitalization.Vigilance disorder (encephalopathy): severity 4; causality - likely device; serious - led to death abdominal pain; encephalopathy; death are anticipated adverse events listed in the ifu/risk management documentation.Conclusion: no batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (device remain implanted in the patient).Additional information has been requested regarding the batch number, treatment dose administrated and patient details regarding disease progression, ascites, bleeding and infection.No product malfunction/deficiency has been identified or reported.No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.

Event Description

Physician reported: "patient post y-90-theraspheres treatment on (b)(6) 2020 without complications.15 days later ((b)(6) 2020), mri-abdomen/pelvis completed.20-21 days later (b)(6) 2020) patient reports pain in right side of his abdomen.Two-three days later on (b)(6) 2020 went to local hospital er and was admitted hospital.On admission= medical history/medication review/physical exam/vitals/review of systems, ct-abdomen and pelvis and clinical labs were obtained with initial upper quadrant abdominal pain, liver masses diagnosis, condition=stable.(b)(6) 2020= mri-abdomen obtained and reviewed with continued right upper quadrant pain.(b)(6) 2020= chest x-ray was obtained and reviewed with continued right upper quadrant pain.Patient did not want to return to columbus, oh for care, so stayed at cambridge, oh hospital and obtained medical records for review.(b)(6) 2020= palliative care consult was ordered and reviewed with continued abdominal pain.(b)(6) 2020= continued review of systems, but patient becoming less responsive, so comfort care, end of life decisions, symptom management reviewed, code status changed to dnrcc and hospice was arranged to cambridge care & rehab and hospice of guernsey.(b)(6) 2020= review of systems, chest x-ray, palliative care and continued to be less responsive.Hospice transfer planned for tomorrow.(b)(6) 2020= cont.Palliative care and recommend keeping him to avoid potential death en route to hospice.Patient passed away 9:30pm.".

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cente; 300 conshohocken state road; west conshohocken,, pa ; 3311537
• MDR Report Key: 9778657
• MDR Text Key: 181731136
• Report Number: 3002124543-2020-00004
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 100