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

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  Death  

Event Description

It was reported via literature article: "mri-derived sarcopenia associated with increased mortality following yttrium-90 radioembolization of hepatocellular carcinoma" death occurred.The purpose of the article is to evaluate the influence of sarcopenia on survival in patients with hepatocellular carcinoma (hcc) treated with 90y radioembolization.A single-center retrospective cohort study analyzed 82 consecutive patients (65 men and17 women, mean age 65 years, range 31-83 years) with hcc treated with 90y radioembolization between december 2013 and december 2017.Sarcopenia was assessed on pre-procedure mri performed within 100 days prior to 90y radioembolization by segmenting the paraspinal musculature at the level of the superior mesenteric artery origin and subtracting fat-intensity pixels to yield fat-free muscle area (ffma).Sarcopenia was defined as ffma b31.97 cm2 for men and b28.95 cm2 for women.Survival at 90 days, 180 days, 1 year, and 3 years following initial treatment was assessed using medical and public obituary records.Sarcopenia was identified in 30% of patients.Death was reported for 49% of males and 71% of females (mean follow-up 19.6 months, range 21 days-58 months).Patients with sarcopenia were found to have increased mortality at 180 days (31.8% vs.8.9%) and 1 year (68.2% vs.21.2%).Sarcopenia was an independent predictor of mortality adjusted for bclc stage and sub-analysis demonstrated that sarcopenia independently predicted increased mortality for patients with bclc stageb disease.

Manufacturer Narrative

Citation: guichet, p.L., taslakian, b., zhan, c., aaltonen, e., farquharson, s., hickey, r., horn, c.J., & gross, j.S.(2021).Mri-derived sarcopenia associated with increased mortality following yttrium-90 radioembolization of hepatocellular carcinoma.Cardiovascular and interventional radiology, 44(10), 1561-1569.Https://doi.Org/10.1007/s00270-021-02874-6.Date of death: between december 2013 and december 2017.Date of event: between december 2013 and december 2017 - unknown date used was the first day of the month bsc was made aware, 1october, 2021.Implant date - between december 2013 and december 2017.

• Brand Name: Y-90 THERASPHERE (3 GBQ) CANADA COMM
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus prk; weydon lane; farnham GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BTG INTERNATIONAL CANADA INC.; 11 hines road; ottawa, ontario K2K 2 X1; CA K2K 2X1
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12816536
• MDR Text Key: 280787457
• Report Number: 2134265-2021-14303
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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: 10/22/2021
• 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): Death