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

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

Patient Problems Abscess (1690); Fever (1858); Hyperbilirubinemia (1903); Muscle Weakness (1967); Pain (1994); Pneumonia (2011); Septic Shock (2068); Stenosis (2263); Ascites (2596); Pseudoaneurysm (2605)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Kim, h., et al.(2021).Yttrium-90 radioembolization for hepatocellular carcinoma: virtual tumor absorbed dose as a predictor of complete response.Anticancer research, 41(5), pp.2625-2635.Date of event was approximated using month of article submission.

Event Description

It was reported via literature article that patient complications occurred.A retrospective single center study was performed to evaluate the impact of virtual tumor absorbed dose (vtad) on tumor response in patients with hepatocellular carcinoma (hcc) treated with yttrium-90 radioembolization.The study was comprised of 100 patients with nodular hcc who underwent yttrium-90 radioembolization between november 2015 and december 2019.Therasphere was a device referenced within the study.Pain during and after procedure, fever, abscess, general weakness, benign biliary stricture, hepatic artery pseudoaneurysm, septic shock, ascites, pneumocystis carinii pneumonia, increased aspartate aminotransferase (ast), increased alanine aminotransferase (alt), and increased total bilirubin were noted to have occurred.Sixteen events of grade 3 or more clinical toxicity occurred in 12 patients (eight patients of vtad less than or equal to 952 gy, four patients of vtad > 952 gy).Grade 3 or more biochemical toxicity developed n 14 patients (five patients of vtad less than or equal to 952 gy, nine patients of vtad > 952 gy).

• Brand Name: Y-90 THERASPHERE (3 GBQ)
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house farnham bus prk; 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 GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12861975
• MDR Text Key: 281158849
• Report Number: 2134265-2021-14746
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Other