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

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

Patient Problems Abdominal Pain (1685); Liver Damage/Dysfunction (1954); Ascites (2596); Decreased Appetite (4569)

Event Date 04/14/2023

Event Type  Injury  

Event Description

Proactif clinical study.It was reported that the patient experienced liver dysfunction.Advanced, multicompartment dosimetry was performed to assess the treatment dose.Pre-treatment macroaggregated albumin (maa) dosimetry documented dose to total perfused liver as 203 gy and dose to total perfused tumor was 350.6 gy.On (b)(6) 2023, 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): 5.558 gbq of therasphere was administered to the right liver through vial 1.In (b)(6) 2023, the subject experienced an alteration in their general health condition.On (b)(6) 2023, 43 days post index procedure, during the consultation, the subject was noted with anorexia, weight loss, and abdominal pain associated with altered general condition.On the same day, encephalopathy score was assessed as grade 1.Additionally, laboratory results revealed 68 micromol/l of bilirubin, asat (aspartate aminotransferase) score was assessed as 2.5n, and tp (total protein) had been assessed as normal.On (b)(6) 2023, ct scan was performed, which revealed the partial response.On (b)(6) 2023, 49 days post index procedure, subject was hospitalized for further treatment and evaluation.On (b)(6) 2023, repeat bilirubin value was assessed as 52 micromole/liter.Additionally, the subject was noted with depressive syndrome.10 mg of oxazepam 3 times per day and 125 ml fortimel protein were administrated.On (b)(6) 2023, the subject was discharged from the hospital.The event was considered resolved.

Manufacturer Narrative

A2: age at time of event: 68 years old at the time of study enrollment.B3: date of event was estimated using date secondary symptoms were observed.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.

Manufacturer Narrative

A2: age at time of event: 68 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 Description

Proactif clinical study: it was reported that the patient experienced liver dysfunction.Advanced, multicompartment dosimetry was performed to assess the treatment dose.Pre-treatment macroaggregated albumin (maa) dosimetry documented dose to total perfused liver as 203 gy and dose to total perfused tumor was 350.6 gy.On (b)(6) 2023, 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): 5.558 gbq of therasphere was administered to the right liver through vial 1.In (b)(6) 2023, the subject experienced an alteration in their general health condition.On (b)(6) 2023, 43 days post index procedure, during the consultation, the subject was noted with anorexia, weight loss, and abdominal pain associated with altered general condition.On the same day, encephalopathy score was assessed as grade 1.Additionally, laboratory results revealed 68 micromol/l of bilirubin, asat (aspartate aminotransferase) score was assessed as 2.5n, and tp (total protein) had been assessed as normal.On (b)(6) 2023, ct scan was performed, which revealed the partial response.On (b)(6) 2023, 49 days post index procedure, subject was hospitalized for further treatment and evaluation.On (b)(6) 2023, repeat bilirubin value was assessed as 52 micromole/liter.Additionally, the subject was noted with depressive syndrome.10 mg of oxazepam 3 times per day and 125 ml fortimel protein were administrated.On (b)(6) 2023, the subject was discharged from the hospital.The event was considered resolved.It was further reported that on (b)(6) 2023, a ct scan revealed the partial regression of hepatic dome lesion, a layer of ascites, persistent right posterior portal thrombosis, and perfusion disorders in the right lateral sector.

• Brand Name: Y-90 THERASPHERE
• Type of Device: 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: 17829748
• MDR Text Key: 324412126
• Report Number: 2124215-2023-52977
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• 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): Hospitalization
• Patient Sex: Male
• Patient Weight: 99 KG