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); Unintended Radiation Exposure (4565)

Event Date 12/06/2020

Event Type  Injury  

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) 2020, the subject presented with abdominal pain (7/10 scale) after radio-embolization.The patient was hospitalized for medical treatment of intravenous morphine 3 mg and oral antalgic treatment.No sign of progression or complication post-embolization.On (b)(6) 2020, the event was considered resolved and the subject was discharged from hospital.

Manufacturer Narrative

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

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) 2020, 23 days post index procedure, the subject presented with abdominal pain (7/10 scale) after radio-embolization.The patient was hospitalized for medical treatment of intravenous morphine 3 mg and oral antalgic treatment.No sign of progression or complication post-embolization.On (b)(6) 2020, the event was considered resolved and the subject was discharged from hospital.

Manufacturer Narrative

G1.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 (b)(6) 2020, 23 days post index procedure, the subject presented with abdominal pain (7/10 scale) after radio-embolization.The patient was hospitalized for medical treatment of intravenous morphine 3 mg and oral antalgic treatment.No sign of progression or complication post-embolization.On (b)(6) 2020, the event was considered resolved and the subject was discharged from hospital.Additional information was received that changed the onset of the abdominal pain to (b)(6) 2020.There was also clarification that during the pre-treatment, the dosimetry method used was standard (single compartment dosimetry) and the planned absorbed dose to total perfused tumor was 120 gy.However, the dosimetry method used post-treatment was multicompartmental and for this reason, the absorbed dose to total perfused tumor was 437 gy.

• 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; chapman house farnham bus prk; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 14874874
• MDR Text Key: 295042654
• Report Number: 2134265-2022-06783
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

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; 05/09/2023
• Supplement Dates FDA Received: 02/21/2023; 06/07/2023
• 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