MAUDE Adverse Event Report: BTG FARNHAM LC BEAD

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

Patient Problems Abdominal Pain (1685); Fatigue (1849); Foreign Body Reaction (1868)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Event date: true event date is unknown.Event date is estimated to the first month of the clinical study (b)(6) 2016.Implant date: between (b)(6) 2016 - (b)(6) 2017.Apa citation: lakhoo, j., adams, r., dave, a., luo, l., vargo, c.J., isaacson, a.J., sher, a., fischman, a., yee, d.C., ryan, s., patel, s., duchac, d., & brown, d.B.(2020).Radiopaque beads loaded with doxorubicin in the treatment of patients with hepatocellular carcinoma: a retrospective, multi-center study.Cancer treatment and research communications, 25, 100208.Https://doi.Org/10.1016/j.Ctarc.2020.100208.

Event Description

It was reported via a retrospective, multi-center study "radiopaque beads loaded with doxorubicin in the treatment of patients with hepatocellular carcinoma" that patients experienced fatigue, abdominal pain and toxicity.The primary objective of this study was to evaluate overall disease and target tumor response of non-resectable hepatocellular carcinoma (hcc) after transarterial chemoembolization (tace) with a doxorubicin-loaded radiopaque microsphere.Data as abstracted from records of patients with unresectable hcc who received tace with doxorubicin loaded radiopaque lc bead lumi microspheres at one of five united states centers between february 2016 - november 2017.82 patients underwent 130 treatments.Most patients, however, received only one (45/82) or two treatments (29/82).Five patients experienced adverse events of fatigue, abdominal pain and toxicity.No grade 4-5 toxicities occurred.No treatment information was supplied in the article.

• Brand Name: LC BEAD
• Manufacturer (Section D): BTG FARNHAM; chapman house; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BTG FARNHAM; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12143519
• MDR Text Key: 260931115
• Report Number: 2134265-2021-08694
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 06/21/2021
• 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