MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (20 GBQ) CE MARK; MICROSPHERES RADIONUCLIDE

Model Number	2361-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: date of birth: 1951.A2: age at time of event: 72 years old at the time of study enrollment.D3: manufacturer address 1: (b)(6).G1: mfr site address 1: (b)(6).G1: mfr site zip/post code: (b)(6).
Event or Problem Description
(b)(6).It was reported the patient experienced asthenia.Advanced, multicompartment dosimetry was performed to assess treatment dose.Pre-treatment macroaggregated albumin (maa) dosimetry documented, dose to total perfused liver was 240.1 gy and dose to total perfused tumor was 387.4 gy.On (b)(6) 2023 the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.The type of therasphere infusion was left liver.The catheter was positioned in the segments ii, iii, iva, ivb; 7.639 gbq of therasphere was administered to the left liver through vial 1.On (b)(6) 2023, 25 days post index procedure, the subject experienced asthenia, anorexia and right abdominal pain.The subject was hospitalized on the same day for treatment and evaluation.Abdominal ct scan revealed tumor progression, occurrence of a left portal branch thrombosis and peri hepatic rim of ascites.Lab results revealed 50 micromole per liter of total bilirubin which was expected to be normalized by (b)(6) 2023.The event was treated with concomitant medication.The condition of the subject improved by treating the events asthenia, anorexia, and abdominal pain through hydration, analgesics like paracetamol and anticoagulation like innohep.On (b)(6) 2023, the event was considered resolved and on the same day the subject was discharged from the hospital with medications (paracetamol and innohep).The thrombosis, ascites, asthenia, anorexia, and abdominal pain were noted to be the consequences of tumor progression.
Additional Manufacturer Narrative
A2: date of birth: 1951.A2: age at time of event: 72 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.
Event or Problem Description
Proactif clinical study it was reported the patient experienced asthenia.Advanced, multicompartment dosimetry was performed to assess treatment dose.Pre-treatment macroaggregated albumin (maa) dosimetry documented, dose to total perfused liver was 240.1 gy and dose to total perfused tumor was 387.4 gy.On (b)(6) 2023 the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.The type of therasphere infusion was left liver.The catheter was positioned in the segments ii, iii, iva, ivb; 7.639 gbq of therasphere was administered to the left liver through vial 1.On (b)(6) 2023, 25 days post index procedure, the subject experienced asthenia, anorexia and right abdominal pain.The subject was hospitalized on the same day for treatment and evaluation.Abdominal ct scan revealed tumor progression, occurrence of a left portal branch thrombosis and peri hepatic rim of ascites.Lab results revealed 50 micromole per liter of total bilirubin which was expected to be normalized by (b)(6) 2023.The event was treated with concomitant medication.The condition of the subject improved by treating the events asthenia, anorexia, and abdominal pain through hydration, analgesics like paracetamol and anticoagulation like innohep.On (b)(6) 2023, the event was considered resolved and on the same day the subject was discharged from the hospital with medications (paracetamol and innohep).The thrombosis, ascites, asthenia, anorexia, and abdominal pain were noted to be the consequences of tumor progression.

• Brand Name: THERASPHERE Y-90 (20 GBQ) CE MARK
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• 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: 18292624
• Report Number: 2124215-2023-67225
• Device Sequence Number: 17816753
• Product Code: NAW
• UDI-Device Identifier: 05060116920338
• UDI-Public: 05060116920338
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 2361-02
• Device Catalogue Number: 2361-02
• Device Lot Number: 2399295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male
• Patient Weight: 110 KG