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 Fever (1858); Pain (1994); Unintended Radiation Exposure (4565)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Proactif clinical study it was reported that fever and moderate epigastric pain occurred.Prior to the procedure, advanced, multicompartment dosimetry was performed to assess the treatment dose.Per treatment tc-maa (technetium macroaggregated albumin) revealed strong uptake by the perfused liver was 250 gy and the perfused tumor was 292.8 gy.On 01-march-2022, the subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.The catheter was positioned in the left hepatic artery (irrespective of origin) (segments ii/iii/iv); 2.944 gbq of therasphere was administered to the left liver through vial 1.Post-treatment dosimetry revealed a strong uptake by the perfused liver which was 479 gy.The higher value of absorbed dose to the perfused liver was due to the treated tumor volume being less than planned (as compared to the pre-treatment dosimetry result).This led to a higher dose delivery, especially in the gastric area.The absorbed dose to the perfused tumor was not determined.On the same day as the index procedure, the subject developed fever and moderate epigastric pain, due to overflow of therasphere into the gastric area from the miscalculation of the perfused tumor volume.As per pre-dosimetry results, the uptake on tc-maa by the perfused liver was noted to be 250 gy.The treatment was administered as per the prescription.However, the treated volume covered was less than planned and post-dosimetry results revealed uptake of the therasphere radiation was 479 gy.Hospitalization was prolonged for further treatment and evaluation.A positron emission tomography (pet) scan revealed very intense and homogenous fixation of yttrium-90.Due to the gastric pain and fever the subject was continuously monitored which led to the prolongation of hospitalization, and concomitant medication was administered to treat the event.On 08-march-2022, the event was considered resolved and the subject was discharged from the hospital on the same day.

Manufacturer Narrative

(b)(6).

• 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: 16728197
• MDR Text Key: 313188471
• Report Number: 2124215-2023-14591
• 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
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• 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: 03/14/2023
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 81 KG