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

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.

• 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: 9872169
• MDR Text Key: 196971429
• Report Number: 3002124543-2020-00009
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2.79 GBQ
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 03/24/2020
• 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): Hospitalization
• Patient Age: 64 YR