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 Dysphagia/ Odynophagia (1815); Inflammation (1932); Necrosis (1971); Pain (1994); Ulcer (2274); Unintended Radiation Exposure (4565)

Event Date 10/09/2021

Event Type  Injury  

Event Description

Proactif clinical study: it was reported that the patient had epigastralgia post therasphere treatment.Standard, single compartment dosimetry was performed to assess treatment dose.Per-treatment tc-maa uptake by the perfused liver was 220 gy.On (b)(6) 2021, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.The therasphere infusion site was selective.Vial 1 of the therasphere was infused to the left liver; 2.497 gbq was administered through the catheter positioning at the left median sector (segment iv).Vial 2 of the therasphere was infused to the right liver; 0.567 gbq was administered through the catheter positioning at the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii): a total of 3.064 gbq was administered.Post treatment dosimetry documented a strong uptake of the delivered dose; to perfused liver was 227 gy and to perfused tumor was 459 gy.On (b)(6) 2021, 3 days post index procedure, subject was hospitalized for epigastralgia post therasphere treatment.The targeted tumor treatment was satisfactory; however, arterial reflux causing the partial necrosis was noted in the stomach which was treated medically.Imaging results revealed inflammatory thickening of the wall of the lesser curvature without perforation.Imaging also revealed a very large stenosing ulcer at the level of the pylorus which caused persistent pain and aphagia.It was treated surgically.On (b)(6) 2021, a gastrectomy of 2/3 was performed.The corrective action taken, was treatment with medication and surgery or interventional radiology procedure was performed.On (b)(6) 2022, the event was considered resolved.On (b)(6)2022, the subject was discharged from the hospital.

Manufacturer Narrative

Date of birth: september 1952.Age at time of event: 69 years old at the time of study enrollment.Manufacturer address 1: chapman house, farnham bus park.Mfr site address 1: chapman house, farnham bus park.Mfr site zip/post code: gu9 8ql.

Manufacturer Narrative

A2: date of birth: (b)(6) 1952.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: (b)(6).

Event Description

Proactif clinical study.It was reported that the patient had epigastralgia post therasphere treatment.Standard, single compartment dosimetry was performed to assess treatment dose.Per-treatment tc-maa uptake by the perfused liver was 220 gy.On (b)(6) 2021, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.The therasphere infusion site was selective.Vial 1 of the therasphere was infused to the left liver; 2.497 gbq was administered through the catheter positioning at the left median sector (segment iv).Vial 2 of the therasphere was infused to the right liver; 0.567 gbq was administered through the catheter positioning at the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii): a total of 3.064 gbq was administered.Post treatment dosimetry documented a strong uptake of the delivered dose; to perfused liver was 227 gy and to perfused tumor was 459 gy.On (b)(6) 2021, 3 days post index procedure, subject was hospitalized for epigastralgia post therasphere treatment.The targeted tumor treatment was satisfactory; however, arterial reflux causing the partial necrosis was noted in the stomach which was treated medically.Imaging results revealed inflammatory thickening of the wall of the lesser curvature without perforation.Imaging also revealed a very large stenosing ulcer at the level of the pylorus which caused persistent pain and aphagia.It was treated surgically.On (b)(6) 2021, a gastrectomy of 2/3 was performed.The corrective action taken, was treatment with medication and surgery or interventional radiology procedure was performed.On (b)(6) 2022, the event was considered resolved.On (b)(6) 2022, the subject was discharged from the hospital.It was further reported that the stenosing ulcer to the antrum was caused by radiation due to diffusion of therasphere because of arterial reflux.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16355074
• MDR Text Key: 309308690
• Report Number: 2124215-2023-03717
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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: 03/21/2023
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 87 KG