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U.S. Department of Health and Human Services

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

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BIOCOMPATIBLES UK LTD THERASPHERE YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT Back to Search Results
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.
 
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Brand NameTHERASPHERE
Type of DeviceYTTRIUM-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 Key10020024
MDR Text Key189692534
Report Number3002124543-2020-00011
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H980006
Number of Events Reported1
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 Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/04/2020 Patient Sequence Number: 1
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