MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT

Model Number UNKNOWN

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

Patient Problems Abdominal Pain (1685); Death (1802); Fatigue (1849); Hiccups (1899); Hyperbilirubinemia (1903); Radiation Sickness Syndrome (2256); Test Result (2695)

Event Type  Death  

Manufacturer Narrative

Company medical assessment comments: this article is a review that aims to provide an overview of the indications, device choice, dosimetry, procedure, clinical outcomes, and toxicity of radiation segmentectomy based on the clinical series of this procedure available to date.What is radiation segmentectomy: it is sirt treatment provided to treat a solitary tumor +/-5 cm (primary or secondary liver tumor); liver-only disease (primary liver tumor without extrahepatic metastasis or secondary liver tumor without other organ metastasis); and a tumor that can be isolated angiographically such that no more than 2 hepatic segments are perfused during treatment.Purpose of rs, therefore, is to deliver an "ablative" dose to a target area in order to completely destroy the tumor along with the tumor-bearing parenchyma.This is achieved by prospectively determining lobar volumes, prescribing an intended lobar dose (>120-150 gy), and administering the dose into the feeding vessel(s) to increase safety and minimize radiation to normal parenchyma.The authors have conducted a systematic search of the literature of studies describing rs published between january 1, 1991 and june 2018, using the keywords "radiation segmentectomy," or "radiation lobectomy," and "english language." a total of 4 retrospective clinical studies were identified through this search.From these studies, a total of 155 cases, including 145 cases of hepatocellular carcinoma (hcc) and 10 cases of hepatic metastases glass microspheres were used in all patients.Of note, 12 cases with segmental portal vein tumor thrombus were included in 1 study.Among the 155 patients 1 patient developed rapidly progressive disease, exhibiting grade 3 bilirubin and albumin toxicity 3 months after rs and dying 4 months after rs.Grade 3 toxicity was reported in 9 patients, and grade 1 and 2 toxicity was reported in 11 patients.Study 1: dose to perfused liver was not reported.Grade 3: rild (n ¼ 3; 4.2%), including 1 patient (1.4%) who developed rapidly progressive disease, exhibited grade 3 rild at month 3, and died 4 months after rs.Study 2: activity administered to perfused liver 1.4 gbq.Grade 3: rild (n = 6; 11%).Study3: dose to perfused liver 261 gy.Grade 1: phrenic irritation (n= 1; 10%).Study 4: dose to perfused liver 255 gy.Grade 1 and 2: fatigue (n= 6; 30%), abdominal pain (n = 2; 10%), postembolization syndrome (n= 2; 10%).The reported events are anticipated events associated with sirt and are listed in the ifu/risk management documentation.No batch review was possible for these cases as the information is from literature and batch number information is not available.The devices will not be returned for evaluation.It is unclear where the events occurred - this is a retrospective review of clinical study cases - therasphere is not commercially available in (b)(6) - but is available in the usa under the hde programme.No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.

Event Description

Review of literature article: radiation segmentectomy for hepatic malignancies: indications, devices, dosimetry, procedure, clinical outcomes, and toxicity of yttrium-90 microspheres.Author: zhongzhi jia a,b, caoye wang c, ricardo paz-fumagalli d, weiping wang et al.A total of 4 retrospective clinical studies were identified through this systematic search.From these studies, a total of 155 cases, including 145 cases of hepatocellular carcinoma (hcc) and 10 cases of hepatic metastases (colorectal cancer, n = 7; breast cancer, n = 1; leiomyosarcoma, n =1; carcinoid tumor, n = 1), were included in the final analysis.Glass microspheres were used in all patients.Of note, 12 cases with segmental portal vein tumor thrombus were included in 1 study.Among the patients enrolled in the 4 studies, only 1 patient developed rapidly progressive disease, exhibiting grade 3 bilirubin and albumin toxicity 3 months after rs and dying 4 months after rs.Grade 3 toxicity was reported in 9 patients, and grade 1 and 2 toxicity was reported in 11 patients grade 3: rild (n = 3; 4.2%), including 1 patient (1.4%) who developed rapidly progressive disease, exhibited grade 3 rild at month 3, and died 4 months after rs grade 3: rild (n = 6; 11%) grade 1: phrenic irritation (n = 1; 10%) grade 1 and 2: fatigue (n = 6; 30%), abdominal pain (n = 2; 10%), postembolization syndrome (n = 2; 10%).

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cntr; 300 conshohocken state road; west conshohocken, pa ; 3311537
• MDR Report Key: 10020133
• MDR Text Key: 189695437
• Report Number: 3002124543-2020-00012
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death