MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-03 for THERASPHERE UNKNOWN manufactured by Biocompatibles Uk Ltd.
[181731136]
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.
Patient Sequence No: 1, Text Type: N, H10
[181731137]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2020-00004 |
| MDR Report Key | 9778657 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SANDRA BAUSBACK-ABALLO |
| Manufacturer Street | 300 FOUR FALLS CORPORATE CENTE 300 CONSHOHOCKEN STATE ROAD |
| Manufacturer City | WEST CONSHOHOCKEN,, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 3311537 |
| Manufacturer G1 | BIOCOMPATIBLES UK |
| Manufacturer Street | CHAPMAN HOUSE WEYDON LANE |
| Manufacturer City | FARNHAM, SURREY GU9 8QL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GU9 8QL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW |
| Product Code | NAW |
| Date Received | 2020-03-03 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES UK LTD |
| Manufacturer Address | CHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, SURREY GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Other | 2020-03-03 |