MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD. THERASPHERE®

Lot Number	1699385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report number: 3002124543-2017-00030.Internal mcn: 2017m5000117.Subject# 0417-004.Last sae report: 24 may 2016.Sae: acute pancreatitis (pancreatitis acute).This sae is linked with unplanned infusion of the total liver, gastric, duodenal and pancreatic because the catheter moved (probably due to a movement of the patient) and sae: hyperthyroidia, captured under mcn# 2017m5000112.This report concerns subject 0417-004, a (b)(6) person who was enrolled in study (b)(6).On (b)(6) 2016, the subject received treatment with study device therasphere® total 67.5 gy for hepatocellular carcinoma in both the lobes (administration of the dose lower than required by protocol is associated with device deficiency reported under mcn# 2017m500071).On (b)(6)2017, the subject commenced treatment with standard of care therapy (sorafenib) at 400 mg po bid and continued this dosage till(b)(6) 2017.From (b)(6)2017 to (b)(6) 2017, standard of care therapy (sorafenib) 400 mg po qd was given reason of reduction is unknown.On (b)(6) 2017, standard of care therapy (sorafenib) was temporarily discontinued due to fatigue.No relevant medical history was reported except for a temporary lipase increase on (b)(6) 2016, consecutive to device administration which was reported under mcn# 2017m5000071.Concomitant medications included bisoprolol, glicazide, omeprazole, clopidogrel, movicol, tramadol, delical and paracetamol.On (b)(6) 2017, the subject was hospitalized with acute pain.The event was diagnosed as acute pancreatitis.On (b)(6) 2017, investigations revealed lipase to be 200 ui/l (normal range <67 ui/l), sgpt test: 180 ui/l (normal range <55 ui/l).Bilirubin and sgot/sgpt results were not available for may 2017.Acute pancreatitis was assessed as grade c as per balthazar score.Prior to subject's hospitalization, relevant labs and tests were as follow: on (b)(6) 2016: lipase test: 33 ui/l (normal range <67 ui/l); sgot test: 51.7 ui/l (normal range <50 ui/l); sgpt test: 57.5 ui/l (normal range <50 ui/l); bilirubin test: 13.7 micro-mol/l (normal range <21); on 30 dec 2016 bilirubin test showed 9 micro-mol/l (normal range <21) and sgot and sgpt tests values were normal (exact values not reported).On (b)(6)2017: lipase test: 42 ui/l (normal range <67 ui/l); bilirubin test: 20.9 micro-mol/l (normal range <21); sgot and sgpt tests were normal (exact values not reported).The event was ongoing at the time of this report and the other details on hospitalization and treatment given was not provided.The subject continued participation in the study.The investigator assessed the event of acute pancreatitis as grade-4 (life threatening) in intensity, serious due to hospitalization.The event was assessed as possibly related to study device.The event was assessed as not related to study procedure, study treatment with standard of care therapy or pre-existing condition.The company assessed the event of acute pancreatitis as grade-4 (life threatening) in intensity, serious due to hospitalization.The event seemed to be unlikely related to study device (due to time lapse between therasphere® administration and onset of the event).The event is not related to study procedure.However, the event seemed to be also possibly related to standard of care therapy (sorafenib).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.
Event or Problem Description
This is a follow-up report to update: linked saes information, additional laboratory tests values, subject's discharge information, investigator's and company's assessment.Mfr report number: 3002124543-2017-00030.(b)(4).Subject# (b)(6).Last reportable sae report: (b)(6) 2017.Sae: acute pancreatitis (pancreatitis acute).This sae is linked with unplanned infusion of the total liver, gastric, duodenal and pancreatic because the catheter moved (probably due to a movement of the patient), sae: hyperthyroidia, captured under mcn# (b)(4) and sae: gastric ischaemia, captured under (b)(4), (emdr mfr# 3002124543-2017-00031).On (b)(6) 2017, lab test results were as follows lipase 132 ui/l (normal value <60 ui/l), bilirubin 20 mmol/l (normal range <17 mmol/l), sgot, sgpt were normal (<50 ui/l), ggt was 117 ui/l (<61ui/l).The subject was discharged on (b)(6) 2017 after showing slight improvement in acute pancreatitis.The subject had not recovered from the event of acute pancreatitis till the time of his death on (b)(6) 2017 due to gastric ischemia (captured under (b)(4), emdr mfr# 3002124543-2017-00031).The event was ongoing at the time of the receipt of this sae and other details on hospitalization and treatment given were not provided.No further supplementary information is expected.The investigator assessed the event of acute pancreatitis as grade-4 (life threatening) in intensity, serious due to hospitalization and as it was a life-threatening experience.The event was assessed as definitely related to study device.The event was assessed as not related to study procedure, study treatment with standard of care therapy (sorafenib) or pre-existing condition.The company assessed the event of acute pancreatitis as grade-4 (life threatening) in intensity, serious due to hospitalization and as it was a life-threatening experience.The event seemed to be possibly related to study device and to study procedure.The event was not related to standard of care therapy (sorafenib).

• 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: 6646543
• Report Number: 3002124543-2017-00030
• Device Sequence Number: 1123014
• Product Code: NAW
• UDI-Device Identifier: 05060116920406
• UDI-Public: 05060116920406
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2017
• Report Date (Section F): 06/02/2017

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: 01/06/2017
• Device Lot Number: 1699385
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/20/2017; 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: BISOPROLOL; CLOPIDOGREL; DELICAL; GLICLAZIDE; MOVICOL; MOVICOL; OMEPRAZOLE; PARACETAMOL; PARACETAMOL; SORAFENIB; TRAMADOL; TRAMADOL
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 71 YR
• Patient Weight: 80
• Date Report Sent to FDA: 06/02/2017