MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED THERASPHERE Y-90 (6.5 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	Ascites (2596)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 66 years old at the time of study enrollment.D3 & g1 - manufacturer address 1: (b)(6).
Event or Problem Description
Proactif clinical study it was reported that the subject experienced edemato-ascitic decompensation 114 days post index procedure.The subject was hospitalized, and intervention was performed as a result.Prior to the index procedure, advanced multicompartment dosimetry was performed to assess treatment dose.Pre-treatment dosimetry documented, dose to total perfused liver was 614 gy and dose to total perfused tumor was 800 gy.On (b)(6) 2023, the subject was enrolled into the proactif clinical study and the treatment with therasphere y-90 glass microspheres was performed on the same day.The type of therasphere infusion was selective.3.143 gbq of therasphere was administered to the left median sector (segment iv).Post treatment dosimetry documented the uptake of the delivered dose to perfused liver was 603 gy.Uptake of the delivered dose to perfused tumor was 758 gy.On 22-nov-2023, the subject presented for a follow-up visit.During this time, ecog score was 1.On 15-dec-2023, 114 days post index procedure, the subject's health condition deteriorated.On the same day, the subject was hospitalized for further treatment and evaluation.During this time, the subject was noted with increased weight to 99 kg.The subject was diagnosed with edemato-ascitic decompensation.Concomitant medication (diuretic treatment) was administrated, and ascites puncture was performed as corrective action to treat the event.Later, the subject's weight was reduced to 85 kg.On (b)(6) 2023, the event was considered resolved and on the same day the subject was discharged from hospital.
Event or Problem Description
Proactif clinical study: it was reported that the subject experienced edemato-ascitic decompensation 114 days post index procedure.The subject was hospitalized, and intervention was performed as a result.Prior to the index procedure, advanced multicompartment dosimetry was performed to assess treatment dose.Pre-treatment dosimetry documented, dose to total perfused liver was 614 gy and dose to total perfused tumor was 800 gy.On (b)(6) 2023, the subject was enrolled into the proactif clinical study and the treatment with therasphere y-90 glass microspheres was performed on the same day.The type of therasphere infusion was selective.3.143 gbq of therasphere was administered to the left median sector (segment iv).Post treatment dosimetry documented the uptake of the delivered dose to perfused liver was 603 gy.Uptake of the delivered dose to perfused tumor was 758 gy.On (b)(6) 2023, the subject presented for a follow-up visit.During this time, ecog score was 1.On (b)(6) 2023, 114 days post index procedure, the subject's health condition deteriorated.On the same day, the subject was hospitalized for further treatment and evaluation.During this time, the subject was noted with increased weight to 99 kg.The subject was diagnosed with edemato-ascitic decompensation.Concomitant medication (diuretic treatment) was administrated, and ascites puncture was performed as corrective action to treat the event.Later, the subject's weight was reduced to 85 kg.On (b)(6) 2023, the event was considered resolved and on the same day the subject was discharged from hospital.
Additional Manufacturer Narrative
Updated fields: d4.A2 - age at time of event: the subject was 66 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 (6.5 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: 19005376
• Report Number: 2124215-2024-18347
• Device Sequence Number: 12870291
• Product Code: NAW
• UDI-Device Identifier: 05060116920390
• UDI-Public: 05060116920390
• 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: 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): 04/09/2024

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: 2399388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 85 KG