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

Model Number 2361-01

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

Patient Problems Liver Damage/Dysfunction (1954); Liver Failure (4492)

Event Date 07/20/2023

Event Type  Death  

Manufacturer Narrative

D3: manufacturer address 1: chapman house, farnham bus park, d3; manufacturer state: on, d3: manufacturer zip/postal code: gu9 8ql, g1: mfr site address 1: chapman house, farnham bus park, g1: mfr site state: on, g1: mfr site zip/post code: gu9 8ql.

Event Description

Mandarin study: it was reported that the patient experienced hepatic insufficiency post-therasphere treatment.On (b)(6) 2023, the subject was enrolled into mandarin study (run-in phase), where the planned treatment type was selective treatment.Treatment with therasphere 12.5 gbq was administered through vial 1 on (b)(6) 2023.The 99mtc-maa angiogram was performed and target volume was 234 cm3.On (b)(6) 2023, the subject was diagnosed with hepatic insufficiency (severe, 3 grade) and lab data revealed increased aspartate aminotransferase (mild, grade 1).It was indicated that the hepatic insufficiency was treated medically.The concomitant oral medications that the patient was taking included 456 mg polyene phosphatidylcholine capsules and 150 mg diammonium glycyrrhizinate enteric-coated capsules.

Event Description

(b)(6) study: it was reported that the patient experienced hepatic insufficiency post-therasphere treatment.On (b)(6) 2023, the subject was enrolled into (b)(6) study (run-in phase), where the planned treatment type was selective treatment.Treatment with therasphere 12.5 gbq was administered through vial 1 on (b)(6) 2023.The 99mtc-maa angiogram was performed and target volume was 234 cm3.On (b)(6) 2023, 90 days post-index procedure, the subject was diagnosed with hepatic insufficiency (severe, 3 grade) and lab data revealed increased aspartate aminotransferase (mild, grade 1).It was indicated that the hepatic insufficiency was treated medically.The concomitant oral medications that the patient was taking included 456 mg polyene phosphatidylcholine capsules and 150 mg diammonium glycyrrhizinate enteric-coated capsules.Additional information was received that on 20-july-2023, one day prior to the diagnosis of hepatic insufficiency, the subject was diagnosed with cirrhosis (mild, grade 1).No action was taken to treat the event.Further information was reported that on (b)(6) 2023, the subject passed away.

Manufacturer Narrative

D3: manufacturer address 1: chapman house, farnham bus park.D3: manufacturer zip/postal code: gu9 8ql.G1: mfr site address 1: chapman house, farnham bus park.G1: mfr site zip/post code: gu9 8ql.

• Brand Name: THERASPHERE Y-90 GLASS MICROSPHERES
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17655558
• MDR Text Key: 322360956
• Report Number: 2124215-2023-46592
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2361-01
• Device Catalogue Number: 2361-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• 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; Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 44 KG