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 Pain (1994); Unintended Radiation Exposure (4565)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Mfr site zip/post code: (b)(4).

Event Description

Proactif clinical study.It was reported that this patient was hospitalized and treated for pain.On (b)(6) 2020 the subject was enrolled into the proactif study and the treatment with y-90 therasphere was performed on the same day in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).A total of 2.206 gbq was administered to the right liver, and post-treatment dosimetry documented a strong uptake of macroaggregated albumin (maa) on tumors; doses to perfused liver was 109 gy and perfused tumor was 437 gy.On 25-jan-2021, 53 days post index procedure, the subject was hospitalized for sudden left basi-thoracic pain.The subject experienced onset of cervical pain lateralized to the left and radiating to the left shoulder that had rapidly progressed for 24 hours.The subject underwent treatment with actiskenan and performed electric discharge concept.On (b)(6) 2021, ct scan was performed which showed a splenic infarction that could explain this pain.Etiology was retained on post-radioembolization and subject treated only with antalgic.On (b)(6) 2021, the event was considered resolved and the subject was discharged from hospital.

Event Description

Proactif clinical study.It was reported that this patient was hospitalized and treated for splenic infarction.On (b)(6) 2021, the subject had received a subsequent therasphere yttrium-90 microspheres treatment.Standard single compartment dosimetry was performed to assess treatment dose.Pretreatment maa imaging documented a strong uptake of maa on tumors, doses to perfused liver and perfused tumor was 128 gy.The type of therasphere infusion was selective.The catheter was positioned in the middle hepatic artery (irrespective of origin) (segment iv), and 0.512 gbq of therasphere was administered to the selective liver through vial 1.Another catheter was positioned in the left hepatic artery (irrespective of origin) (segments ii/iii/iv), and 1.098 gbq of therasphere was administered to the selective liver through vial 2.A total 1.61 gbq of activity was administered during the subsequent treatment.Post- treatment dosimetry documented a strong uptake of the delivered dose; 88 gy to the perfused liver and 265 gy to the perfused tumor.On (b)(6) 2021, the subject had a sudden onset of pain in the left basal thoracic region.The subject was hospitalized the next day for further treatment and management of event.On (b)(6) 2021, ct scan revealed a splenic infarction that could explain this pain.The pain rapidly progressed within 24 hours and the cervical pain lateralized to the left, radiating to the left shoulder.The sensation of pain was like an electric discharge.The subject was treated with analgesic for the pain (actiskenan, skenan and paracetamol).The etiology was considered as post-radioembolization.On (b)(6) 2021, the event was considered resolved and the subject was discharged from hospital.

Manufacturer Narrative

G1.Mfr site zip/post code: gu9 8ql.

Manufacturer Narrative

G1.Mfr site zip/post code: gu9 8ql.

Event Description

Proactif clinical study.It was reported that this patient was hospitalized and treated for pain.On (b)(6) 2020 the subject was enrolled into the proactif study and the treatment with y-90 therasphere was performed on the same day in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).A total of 2.206 gbq was administered to the right liver, and post-treatment dosimetry documented a strong uptake of macroaggregated albumin (maa) on tumors; doses to perfused liver was 109 gy and perfused tumor was 437 gy.On (b)(6) 2021, 53 days post index procedure, the subject was hospitalized for sudden left basi-thoracic pain.The subject experienced onset of cervical pain lateralized to the left and radiating to the left shoulder that had rapidly progressed for 24 hours.The subject underwent treatment with actiskenan and performed electric discharge concept.On (b)(6) 2021, ct scan was performed which showed a splenic infarction that could explain this pain.Etiology was retained on post-radioembolization and subject treated only with antalgic.On (b)(6) 2021, the event was considered resolved and the subject was discharged from hospital.

• 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; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 14874760
• MDR Text Key: 295048467
• Report Number: 2134265-2022-06854
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 02/21/2023; 03/17/2023
• Supplement Dates FDA Received: 02/21/2023; 03/24/2023
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 68 KG