MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number	990700.SPE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Ascites (2596); Swelling/ Edema (4577)
Date of Event	08/24/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Medical assessment from the manufacturer concurred with the reported causal relationship between the device, and the adverse event.Ascites, edema, and hepatic decompensation are listed as potential adverse events within the ifu.The tumours and portal vein thrombosis exhibited strong 99tc-maa during the pre-treatment work-up.Post treatment dosimetry was not performed by the treating physician.The clinical deterioration of the patient's condition was documented by grade 2 hyperbilirubinemia and grade 3 ascites.The patient required paracentesis and diuretic treatment.
Event or Problem Description
Patient: (b)(6), with an infiltrative hcc tumour in the right and left liver, was enrolled in the (b)(6) on (b)(6) 2020.The patient was treated using a selective approach with 2 vials.The delivered dose to the perfused, and whole liver is currently undetermined.On (b)(6) 2020, the subject developed edematous ascites decompensation, assessed as grade 3 according to the ctcae v5.0.The resolution of the adverse event is currently unknown.The adverse event was assessed by the physician as definitely related to the procedure.The event was initially reported as an adverse event, but not a serious adverse event, but required a surgical procedure, and concomitant medication to resolve.
Additional Manufacturer Narrative
Medical assessment from the manufacturer concurred with the reported causal relationship between the device and the adverse event.Ascites, edema and hepatic decompensation are listed as potential adverse events within the ifu.The tumours and portal vein thrombosis exhibited strong 99tc-maa during the pre-treatment work-up.Post treatment dosimetry was not performed by the treating physician.The clinical deterioration of the patient's condition was documented by grade 2 hyperbilirubinemia and grade 3 ascites.The patient required paracentesis and diuretic treatment.Additional information: medical assessment from the manufacturer assessed the reported adverse event as a liver failure (grade 4 according to ctcae v5.0), and noted that hte patient additionally presented with hepatorenal syndrome with impaired renal function.
Event or Problem Description
Patient (b)(6) with an inflitrative hcc tumour in the right and left liver was enrolled in the proactif registry on (b)(6) 2020.The patient was treated using a selective approach with 2 vials.The delivered dose to the perfused and whole liver is currently undetermined.On (b)(6) 2020 (day not specified), the subject developed edematous ascites decompensation, assessed as grade 3 according to the ctcae v5.0.The resolution of the adverse event is currently unknown.The adverse event was assessed by the physician as definitely related to the procedure.The event was initially reported as an adverse event but not a serious adverse event, but required a surgical procedure and concomitant medication to resolve.Additional information reported on 21-oct-2020: the patient was admitted to the institution on the (b)(6) 2020, with the adverse event becoming serious on the (b)(6) 2020, with a fatal outcome.
Additional Manufacturer Narrative
H3 - device evaluated by manufacturer: the lot number was not reported and therefore a manufacturing batch record review could not be completed.The device remains implanted and will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was further reported that in (b)(6) 2020, the subject was hospitalized for the event.The subject's health condition continued to worsen.The subject had completely lost independence, with presentation of early hepatic encephalopathy.On arrival to the hospital, in the early afternoon, the subject was noted to be very drowsy, with jerky, rapid, shallow breathing combined with indrawing.It was also noted that there were no verbal or visual contact.The subject had extremely rapid deterioration of health over the past few days, with widespread, unsystematic pain, associated with breathing difficulties.She also observed very watery stools with red blood loss in the toilet.The subject was immediately initiated with symptomatic treatments, primarily with low flow oxygen and oxycodone, quickly enabling an improvement in breathing.116 days post index procedure, the subject died due to hepatic decompensation.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 10659504
• Report Number: 3002124543-2020-00019
• Device Sequence Number: 3564415
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2021

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: Health Professional
• Device Model Number: 990700.SPE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 10/21/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/18/2020; 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 67 YR