MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (3 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 Codes	Fatigue (1849); Muscle Weakness/Atrophy (1967)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 79 years old at the time of study enrollment.D3 & g1: manufacturer address 1: (b)(4).D3 & g1: manufacturer zip/postal code: (b)(4).
Event or Problem Description
Proactif (b)(4).It was reported that the patient was hospitalized as a result of intense fatigue.Standard, single compartment dosimetry was performed to assess treatment dose.Pre-treatment maa dosimetry documented, dose to total perfused liver was 119.8 gy and dose to total perfused tumor was 409.8 gy.On (b)(6) 2020, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion for vial 1 was right liver.The catheter was positioned in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii): 2.677 gbq of therasphere was administered to the right liver through vial 1.Post treatment dosimetry results were not determined.On (b)(6) 2020, 13 days post index procedure the subject experienced intense fatigue.On the same day, the subject was admitted in the hospital for the further treatment and evaluation.On (b)(6) 2020, during hospitalization, ecog score was assessed as 1.Encephalopathy and ascites score were assessed as 0.Concomitant medication was administrated to treat the event.On (b)(6) 2020, the event was considered resolved and on the same day subject was discharged from the hospital.
Additional Manufacturer Narrative
A1: patient identifier: (b)(6).A2: age at time of event: the subject was 79 years old at the time of study enrollment.D3 & g1: manufacturer address 1: (b)(4).Updated fields: b5: describe event or problem.H6: patient codes.
Event or Problem Description
Proactif: (b)(4).It was reported that the patient was hospitalized as a result of intense fatigue.Standard, single compartment dosimetry was performed to assess treatment dose.Pre-treatment maa dosimetry documented, dose to total perfused liver was 119.8 gy and dose to total perfused tumor was 409.8 gy.On (b)(6) 2020, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion for vial 1 was right liver.The catheter was positioned in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii): 2.677 gbq of therasphere was administered to the right liver through vial 1.Post treatment dosimetry results were not determined.On (b)(6) 2020, 13 days post index procedure the subject experienced intense fatigue.On the same day, the subject was admitted in the hospital for the further treatment and evaluation.On (b)(6) 2020, during hospitalization, ecog score was assessed as 1.Encephalopathy and ascites score were assessed as 0.Concomitant medication was administrated to treat the event.On 29-jun-2020, the event was considered resolved and on the same day subject was discharged from the hospital.It was further reported that the event of asthenia was caused as a secondary event of radioembolization and there was no other cause for the event.
Event or Problem Description
Proactif (b)(4).It was reported that the patient was hospitalized as a result of intense fatigue.Standard, single compartment dosimetry was performed to assess treatment dose.Pre-treatment maa dosimetry documented, dose to total perfused liver was 119.8 gy and dose to total perfused tumor was 409.8 gy.On (b)(6) 2020, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion for vial 1 was right liver.The catheter was positioned in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii): 2.677 gbq of therasphere was administered to the right liver through vial 1.Post treatment dosimetry results were not determined.On (b)(6)2020, 13 days post index procedure the subject experienced intense fatigue.On the same day, the subject was admitted in the hospital for the further treatment and evaluation.On (b)(6)2020, during hospitalization, ecog score was assessed as 1.Encephalopathy and ascites score were assessed as 0.Concomitant medication was administrated to treat the event.On (b)(6)2020, the event was considered resolved and on the same day subject was discharged from the hospital.It was further reported that the event of asthenia was caused as a secondary event of radioembolization and there was no other cause for the event.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: the subject was 79 years old at the time of study enrollment.D3 & g1 - manufacturer address 1: (b)(6).D3 & g1 - manufacturer zip/postal code: (b)(6).

• Brand Name: THERASPHERE Y-90 (3 GBQ) CE MARK
• Common Device Name: 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: 17882486
• Report Number: 2124215-2023-54021
• Device Sequence Number: 7409673
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2024

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: 2399268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 01/11/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/01/2023; 01/16/2024
• 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: 70 KG