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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 2.79 GBQ
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Encephalopathy (1833); Hemorrhage/Bleeding (1888)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative
Btg/bsc medical assessment comments: patient with hcc occurring on alcoholic cirrhosis, right liver tumor. At baseline, alteration of liver function (albumin 26g/l) portal hypertension (splenomegaly, platelet count decrease) and invasion of the main trunk of the portal vein and/or contra-lateral portal vein branch to the primarily involved lobe. The patient was administered therasphere on (b)(6) 2015. Activity was 2. 79 gbq and lung shunting was 5. 2%. The total volume of perfused liver was 1189. 3 cc, or 65. 9% of the total liver volume, which had an associated absorbed dose of 108. 7 gy. The whole liver received a dose of 71. 6 gy. Whole liver normal tissue had an absorbed dose totaling 59. 8 gy. On (b)(6) 2015, the subject developed digestive haemorrhage and encephalopathy increased from absent to grade 3 to 4. End date of the event (b)(6) 2015. At the first follow-up visits after treatment with therasphere, (b)(6) 2015, ecog deterioration to grade 2 hematology, hemoglobin 8. 4g/dl, platelet low 93 10^9/l and biochemistry: albumin 28g/l, bilirubin 27 micromol/l remained consistent with baseline, alp, ggt and afp decreased. It is likely that therasphere administration led to a transient increase of portal hypertension in a patient with pre-existing portal hypertension (thrombocytopenia, splenomegaly). As a consequence of increased portal hypertension there was bleeding of existing esophagus varices not documented at baseline. There was no device malfunction. Encephalopathy: severity 3; serious; anticipated; related to digestive haemorrhage (outcome). Digestive hemorrhage: severity 4; serious; anticipated; related to device. No batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (device remains implanted in the patient). 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
This (b)(6) year old male patient with hcc experienced encephalopathy and digestive hemorrhage following treatment with therasphere. The event led to hospitalization. The patient subject (b)(6) participated in a retrospective study of therasphere treatment for hcc, the target trial. The patient had a history of cirrhosis due to alcohol abuse and chronic bronchitis and increased ggt levels. The patient was diagnosed with hcc right lobe disease in (b)(6) 2014. Before therasphere treatment, the patient had an ecog score of 0, liver function was child-pugh class b7 and hcc staging was bclc c. The patient had portal hypertension with splenomegaly noted at baseline. The patient had no disease related surgery and was not treated with sorafenib before therasphere treatment. Albumin, platelet count and hemoglobin values were lower than normal. Ggt, alp, aat, afp and creatinine were elevated at baseline. Albumin (26 g/l) was below the lower reference range. Labs collected at baseline although outside of the given reference ranges were not contraindications to the protocol. The patient was administered therasphere on (b)(6) 2015. Activity was 2. 79 gbq and lung shunting was 5. 2%. The total volume of perfused liver was 1189. 3 cc, or 65. 9% of the total liver volume, which had an associated absorbed dose of 108. 7 gy. The whole liver received a dose of 71. 6 gy. Whole liver normal tissue had an absorbed dose totaling 59. 8 gy. On (b)(6) 2015, the subject developed digestive hemorrhage and encephalopathy increased from absent to grade 3 to 4. At the first follow-up visits after treatment with therasphere, (b)(6) 2015, hematology and biochemistry remained consistent with baseline, bilirubin & aat exceeded the upper limit of normal (not significantly). Alp, ggt and afp decreased. Digestive hemorrhage was treated by esophageal vein ligation, and encephalopathy was treated by administration of duphalac. The events were resolved in (b)(6) 2015. The last follow-up time point data was collected on (b)(6) 2015. At this time albumin remained lower than the reference range and bilirubin fell back within normal range. Aat and alp remained elevated. The subject died on (b)(6) 2015. Cause of death was unknown. The investigator assessed this event as unlikely related to therasphere.
 
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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 Key9872169
MDR Text Key196971429
Report Number3002124543-2020-00009
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2.79 GBQ
Device Catalogue NumberN/A
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 Received03/20/2020
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: 03/24/2020 Patient Sequence Number: 1
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