MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD. THERASPHERE®

Lot Number	1799068
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Renal Failure (2041); Ascites (2596)
Date of Event	04/20/2017
Type of Reportable Event	Death
Event or Problem Description
(b)(4).Subject #: (b)(6).Last sae report: 12 jun 2017.Sae: ascites (ascites).This report concerns subject (b)(6) caucasian male who was enrolled in study (b)(6) of intra-arterial therasphere® in the treatment of patients with unrespectable hepatocellular carcinoma (hcc).On (b)(6) 2017, the subject received treatment with study device therasphere® for hepatocellular carcinoma with dose of 120 gy to the right lobe and on (b)(6) 2017, with dose of 90 gy to the left lobe.The subject had not received treatment with standard of care therapy (sorafenib) as the subject's condition was unstable post treatment with therasphere® due to worsening of kidney function.Relevant medical history included hepatocellular carcinoma, hypertension and type-2 diabetes.Concomitant medications included adalat, allopurinol and crestor.On (b)(6) 2017, post treatment with study device the subject had increased ascites and weakness.On (b)(6) 2017, the subject was hospitalized for parenthesis to control ascites.The subject was given albumin post parenthesis (as the drainage was bloody).He was also treated with morphine 5mg iv prn for pain control and dosage of diuretics was increased.The subject also started zofran 4-8 mg po prn.On (b)(6) 2016, subject was still in the hospital with increased nausea and was being treated with maxeran.The subject's condition was unstable with worsening of kidney function.The subject had oliguria with creatinine values more than 600.Initially, the subject was placed on treatment for hepatorenal syndrome including midodrine, octreotide and albumins but there was no response.Urinalysis was not consistent with hepatorenal syndrome.The subject had acute renal failure.The subject was transferred to palliative care.On (b)(6) 2017, while still in the hospital on palliative care, the subject died.The subject discontinued participation in the study due to his death.The investigator assessed the event of ascites as grade-5 (fatal) in intensity, serious due to death of the subject.The event was assessed as not related to study device and as possibly related to study procedure.The event was not related to pre-existing condition and standard of care therapy (sorafenib).The event was considered as related to disease under study.The company agreed with investigators assessment.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 sae term adding event of acute renal failure.No new information has been received.Update to sae term: ascites (ascites); acute renal failure (acute kidney injury).Mfr report number: 3002124543-2017-00027.Internal mcn: 2017m5000082.Subject #: 0202-016.Last sae report: (b)(6) 2017.Sae term: ascites (ascites); acute renal failure (acute kidney injury).
Event or Problem Description
This is a follow-up report to update date of death, outcome and severity grade for the event of ascites.Mfr report number: 3002124543-2017-00027.Internal mcn: (b)(4).Subject #: (b)(6).Last sae reports: 26 jul 2017 & 01 aug 2017.Sae: ascites (ascites); acute renal failure (acute kidney injury).On (b)(6) 2017, the subject died due to progression of hcc.At the time of death, the subject was recovering/resolving from the event of ascites.The investigator assessed the event of ascites as grade-4 (life-threatening).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, outcome for the event of ascites.Mfr report number: 3002124543-2017-00027.Internal mcn: (b)(4).Subject #: (b)(6).Last sae reports: 01-aug-2019.Sae: ascites (ascites); acute renal failure (acute kidney injury).On (b)(6) 2017, the subject died due to progression of hcc.At the time of death, the subject was not recovered/not resolved from the event of ascites.No further information is expected.

• Brand Name: THERASPHERE®
• Common Device Name: THERASPHERE®
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD.; chapman house farnham business; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 6676235
• Report Number: 3002124543-2017-00027
• Device Sequence Number: 57457
• Product Code: NAW
• UDI-Device Identifier: 05060116920314
• UDI-Public: 05060116920314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/01/2019

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: Other
• Device Expiration Date: 05/18/2017
• Device Lot Number: 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: 05/30/2017
• Supplement Date Received by Manufacturer: 06/26/2017; 07/26/2017; 07/26/2017; 08/01/2019
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 07/26/2017; 08/24/2017; 10/31/2017; 08/23/2019
• 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: ADALAT; ALLOPURINOL; CRESTOR; ADALAT; ALLOPURINOL; CRESTOR
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 76 YR
• Patient Weight: 93