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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW Back to Search Results
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
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45. 0-39. 9), tia, congestive heart failure, hypertension, bronchitis, benign prostatic hypertrophy, arthritis, osteoarthritis and depression, dysphagia, prior patient liver disease history
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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
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stable. (b)(6) 2020
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mri-abdomen obtained and reviewed with continued right upper quadrant pain. (b)(6) 2020
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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
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palliative care consult was ordered and reviewed with continued abdominal pain. (b)(6) 2020
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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
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review of systems, chest x-ray, palliative care and continued to be less responsive. Hospice transfer planned for tomorrow. (b)(6) 2020
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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
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(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:
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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. ".
 
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Brand NameTHERASPHERE
Type of DeviceYTTRIUM-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 Key9778657
MDR Text Key181731136
Report Number3002124543-2020-00004
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
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 Treatment Data
Date Received: 03/03/2020 Patient Sequence Number: 1
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