MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD. THERASPHERE®

Lot Number	1799036; 1799068
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Liver Damage/Dysfunction (1954)
Date of Event	03/30/2017
Type of Reportable Event	Death
Event or Problem Description
(b)(4).Subject number: (b)(6).Last sae report: (b)(6) 2017.Sae: liver decompensation (hepatic failure) this report concerns subject (b)(6) male who was enrolled in study (b)(6) entitled "a phase iii clinical trial of intra-arterial therasphere® in the treatment of patients with unresectable hepatocellular carcinoma (hcc).The subject received treatment with study device therasphere® 128 gy to the right lobe on (b)(6) 2017 and 120 gy to the left hepatic lobe on (b)(6) 2017 for hepatocellular carcinoma.At the time of this event, treatment with standard of care therapy (sorafenib) was not initiated for the subject.The subject's past medical history included appendicitis, petrous bone fracture, coma, (b)(6), meniscus injury, meniscectomy, ongoing medical history included high blood pressure, depressive syndrome, pruritus and icterus.Concomitant medications included citalopram, valsartan and atarax.On (b)(6) 2017 respectively, prior to hospitalization, the subject's bilirubin levels were 55 mmol/l, 143 micromol/l (normal range: 3-17 micromol/l).The subject had icterus and increased abdominal perimeter and hence was hospitalized for ascitic puncture on (b)(6) 2017.5.5 liters of fluid was drained which was then compensated by 2 albumin vials.The subject's scan showed ascites, decompensation and hepatic carcinoma progression with bilirubin level at 236 micromol/l.The subject was treated with the following medications: lactulose orally 2 bags twice daily, nefopam orally 1 vial four times a day as needed, paracetamol orally 1 gm three times a day as needed, norfloxacin orally 400 mg once daily and amphotericin orally 1 teaspoon three times a day for 7 days.On (b)(6) 2017, the subject was discharged with bilirubin level at 170 micromol/l.On (b)(6) 2017, the subject was re-hospitalized for ascitic puncture with bilirubin levels at 122 micromol/l and discharged on (b)(6) 2017.On (b)(6) 2017, the subject underwent ascitic puncture without hospitalization and bilirubin levels at 115 micromol/l.Commencing treatment with standard of care therapy (sorafenib) was planned at this time , but was not administered, it was planned to start only after re-evaluation.On (b)(6) 2017, the subject again underwent ascitic puncture.On (b)(6) 2017, the subject died due to liver decompensation due to liver carcinoma.The subject discontinued participation in the study due to his death.The investigator assessed the event of liver decompensation as grade 3 (severe) in intensity, serious due to hospitalization, being life threatening, and death of the subject.The event was assessed as possibly related to study device and not related to study procedure, to standard of care therapy (sorafenib) and to pre-existing condition.The event was considered as related to disease under study (hepatocellular carcinoma).The company assessed the event of liver decompensation as grade 5 (fatal) in intensity, serious due to hospitalization, being life threatening and death of the subject.The event was assessed as related to study device and to the subject's pre-existing condition of hepatocellular carcinoma.The event was considered as not related to study procedure, to standard of care therapy (sorafenib).A supplemental report will be submitted if additional relevant information is received.
Event or Problem Description
This is a follow-up report to update the severity grade for the event of liver decompensation and details regarding cause of death.Mfr # 3002124543-2017-00036.Internal mcn: (b)(4).Last sae report: (b)(6) 2017.Sae: liver decompensation (hepatic failure).On (b)(6) 2017, the subject died due to liver decompensation.The investigator assessed the event of liver decompensation as grade-5 (fatal).A supplemental report will be submitted if additional relevant information is received.
Event or Problem Description
This follow-up report is being sent to correct pma/510(k) number to h980006.

• Brand Name: THERASPHERE®
• Common Device Name: THERASPHERE®
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD.; chapman house farnham business; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 6750391
• Report Number: 3002124543-2017-00036
• Device Sequence Number: 16306850
• Product Code: NAW
• UDI-Device Identifier: 05060116920413
• UDI-Public: 05060116920413
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/17/2017
• Device Lot Number: 1799036; 1799068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 07/31/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/29/2017; 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPHOTERICINE; ATARAX; CITALOPRAM; LACTULOSE; NEFOPAM; NORFLOXACINE; PARACETAMOL; VALSARTAN
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening
• Patient Age: 68 YR