MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE; MICROSPHERES RADIONUCLIDE

Lot Number 2199439

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pleural Effusion (2010); Decreased Appetite (4569)

Event Date 09/26/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) at the time of study enrollment.

Event Description

Mandarin study.It was reported that the subject experienced pleural effusion, requiring intervention.On (b)(6) 2021, the subject was enrolled into mandarin study.Planned treatment type was uni-lobar treatment.Treatment with therasphere was performed on the same day.Total calibrated activity prior to infusion was 3.12 gbq and calculated dose to perfused target liver tissue was 213.49 gy.On (b)(6) 2021, 2 days post therasphere procedure, the subject experienced loss of appetite and was noted with fever.Both events were considered mild.No action was taken to treat the events.The events were considered resolved within 1-2 days.On (b)(6) 2021, 21 days post therasphere procedure, the subject experienced loss of appetite.No action was taken to treat the event.The event was considered resolved on (b)(6) 2021.On (b)(6) 2021, 36 days post therasphere procedure, the subject experienced pleural effusion.Pleural puncture was performed as an interventional procedure.On (b)(6) 2021 the event was considered resolved.

Event Description

Mandarin study: it was reported that the subject experienced pleural effusion, requiring intervention.On (b)(6) 2021, the subject was enrolled into mandarin study.Planned treatment type was uni-lobar treatment.Treatment with therasphere was performed on the same day.Total calibrated activity prior to infusion was 3.12 gbq and calculated dose to perfused target liver tissue was 213.49 gy.On (b)(6) 2021, 2 days post therasphere procedure, the subject experienced loss of appetite and was noted with fever.Both events were considered mild.No action was taken to treat the events.The events were considered resolved within 1-2 days.On (b)(6) 2021, 21 days post therasphere procedure, the subject experienced loss of appetite.No action was taken to treat the event.The event was considered resolved on (b)(6) 2021.On (b)(6) 2021, 36 days post therasphere procedure, the subject experienced pleural effusion.Pleural puncture was performed as an interventional procedure.On 16-nov-2021 the event was considered resolved.It was further reported that on (b)(6) 2021, 99mtc-maa angiogram was performed, and tumor volume/target volume was 552 cm3.10.5 gbq was administered through vial 1.

Manufacturer Narrative

A2: age at time of event: 45 years old at the time of study enrollment.D3: manufacturer address 1: chapman house, farnham bus park.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site zip/post code: gu9 8ql.

• Brand Name: Y-90 THERASPHERE
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 13334071
• MDR Text Key: 284300100
• Report Number: 2134265-2022-00442
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 2199439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 73 KG