BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT
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Model Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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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)
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Event Type
Death
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Manufacturer Narrative
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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).
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Event Description
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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.
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