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); Encephalopathy (1833); Fatigue (1849); Hemorrhage/Bleeding (1888); Hyperbilirubinemia (1903); Liver Damage/Dysfunction (1954); Nausea (1970); Ascites (2596); Test Result (2695)

Event Type  Death  

Manufacturer Narrative

Company medical assessment comments: study from april 2005 to december 2018, 91 consecutive patients with bclc stage c hcc who underwent y90 sirt were retrospectively analyzed.The purpose of this retrospective study was thus to assess the outcomes of patients with child-pugh b7 disease treated with y90 sirt for advanced hcc to determine whether outcomes compare more to those with child-pugh a disease versus those with more advanced, child-pugh b8/9 liver disease.Furthermore, the weighted effects of the individual components of child-pugh score were also assessed.Population mean age was 63 years and 85.7% were male.(b)(6) infection was the most common etiology of liver disease (58.2%).Sixty-four (70.3%) patients were child-pugh a, 19 (20.9%) patients were b7, and eight (8.8%) patients were b8-9.64 (70.3%) patients were child-pugh a, 19 (20.9%) patients were b7, and 8 (8.6%) patients were b8/9.55 (60.4%) were ecog score 0, the mean tumor size was 7.4 cm (range, 2.0-19.8) and 47 patients (51.6%) had one tumor.Treatment and follow-up the mean administered activity of y90 was 3.30 gbq (, 0.42-9.45).80 (87.9%) patients were treated with lobar delivery, and 11 (12.1%) patients received segmental y90 delivery.Follow-up clinical and laboratory testing was done one month after the procedure.Contrast-enhanced cross-sectional imaging was performed one month after the procedure and every three months thereafter.Results frequent adverse events were abdominal/back pain in 32 patients (35.2%), fatigue in 26 patients (28.6%), nausea/vomiting in 15 patients (16.5%).One patient had melenae at the sixth-day post-procedure.30 days mortality rate was 1.1%.One patient with pvi and child-pugh b7 disease died 22 days after radioembolization.Testing at that time revealed significant tumor progression and liver dysfunction with elevated (ast 516 u/l, alt 243 u/l) and hyperammonemia (71 umol/l).

Event Description

As part of post-market surveillance activities literature article: yttrium-90 radioembolization for bclc stage c hepatocellular carcinoma comparing child-pugh a versus b7 patients: are the outcomes equivalent? author: qingquan zu et al was reviewed.The purpose of this retrospective study was to specifically assess the outcomes of patients with child-pugh b7 disease treated with y90 radioembolization for advanced hcc to determine whether outcomes compare more to those with child-pugh a disease versus those with more advanced, child-pugh b8/9 liver disease.Furthermore, the weighted effects of the individual components of child-pugh score were also assessed.106 patients with barcelona clinic liver cancer (bclc) stage c hepatocellular carcinoma (hcc) who underwent y90 radioembolization (therasphere) at a tertiary referral center were retrospectively analyzed in this single-center study.Data collected included patient characteristics, liver function, and tumor characteristics.Hcc was confirmed by multiphasic contrast-enhanced abdominal ct or mri, serum alpha-fetoprotein (afp) levels, or biopsy.Clinical performance status was evaluated according to the eastern cooperative oncology group (ecog) score.The child-pugh score was independently assessed and categorized as: a (score = 5/6), b7 (score = 7), and b8/9 (score = 8/9)[9].Macrovascular tumor invasion was diagnosed on contrast-enhanced ct/mri.Additional tumor characteristics including size, lesion number, distribution, and growth pattern were also evaluated.Follow-up clinical and laboratory testing was done one month after the procedure.Contrast-enhanced crosssectional imaging was performed one month after the procedure and every three months thereafter.Event: common post-radioembolization adverse events were abdominal/back pain in 32 patients (35.2%), fatigue in 26 patients (28.6%), nausea/vomiting in 15 patients (16.5%).One patient experienced a dark bloody bowel movement at the sixth-day post-procedure.All patients recovered with conservative treatment.One patient with pvi and child-pugh b7 disease died 22 days after radioembolization.Testing at that time revealed significant tumor progression and liver dysfunction with elevated aspartate and alanine aminotransferases (ast 516 u/l, alt 243 u/l) and hyperammonemia (71 umol/l).Fatigue, abdominal pain, nausea, ascites; encephalopathy, increased albumin; increased bilirubin; gi bleed are anticipated adverse event associated with sirt listed in the ifu/risk management documentation.

• 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: 10020024
• MDR Text Key: 189692534
• Report Number: 3002124543-2020-00011
• 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: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2020

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
• Is this a Product Problem Report?: No
• 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: 04/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death