MAUDE Adverse Event Report: BIOCOMPATIBLES LTD. Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE

Model Number 2361-01

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

Patient Problem Necrosis (1971)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

Journal article: jia, zhongzhi, and weiping wang. "hepatic necrosis following yttrium-90 radioembolization for hepatocellular carcinoma in a patient with a recent history of external radiotherapy. " journal of cancer research and therapeutics 17. 4 (2021): 1104. Date of death, date of event, implant date: dates were approximated based on month of article submission.

Event Description

It was reported via a journal article that patient complications occurred. At 55 days after 90 y treatment, a repeat contrast enhanced ct scan demonstrated a new low attenuation lesion in the right lobe, in addition to the irregularly shaped low attenuation lesions at the dome. Mri confirmed the presence of this new low attenuation lesion, and mr results suggested that this lesion was liquid in nature. Because the patient's symptoms were worsening, she agreed to have a percutaneous drain placed, and a 10 fr pigtail catheter was inserted into the new low-attenuation lesion. When the catheter was injected, the contrast material was seen in the low-attenuation lesions at the dome via multiple connections from the cavity. A total of 30 ml of necrotic material was aspirated during the procedure, but the cultures of this material were negative. After drain placement, the output gradually transitioned to pure bile, with a daily output of approximately 80-120 ml. The biloma cavity eventually resolved over the next 5 weeks of external drainage, and the drain was converted to an internal/external biliary drain. The catheter was capped to internal drainage with the intention of possibly removing the catheter if clinical stability was documented. Unfortunately, the patient's overall condition continued to deteriorate as the disease progressed, and she died 6 months after 90y treatment.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES LTD.; chapman house, farnham bus prk; weydon lane; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12994489
• MDR Text Key: 282179480
• Report Number: 2134265-2021-15151
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 2361-01
• Device Catalogue Number: 2361-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/14/2021 Patient Sequence Number: 1