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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE Y-90 GLASS MICROSPHERES; MICROSPHERES RADIONUCLIDE
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BIOCOMPATIBLES UK LTD THERASPHERE Y-90 GLASS MICROSPHERES; MICROSPHERES RADIONUCLIDE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Ascites (2596); Thrombosis/Thrombus (4440)
Event Date 09/26/2020
Event Type  Injury  
Manufacturer Narrative
This event was original reported under legacy btg mfr report #3002124543-2021-00014.This follow up report is being sent to capture additional information that has been received.
 
Event Description
It was reported that abdominal pain occurred.In (b)(6) 2020, subject (b)(6) subject was enrolled into the (b)(6) study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was in the right hepatic artery (irrespective of origin) (segmentsv/vi/vii/viii).7.30 gbq was administered to the liver (right liver) through vial 1.9 days post treatment with therasphere, the subject presented with abdominal pain.In (b)(6) 2020, 25 days later, the subject was hospitalized in other institution for further evaluation and treatment.As a treatment, the subject was prescribed with lovenox, oxynorm bro 5 mg and innohep 18000 u.5 days later, the subject was discharged from hospital.In (b)(6) 2020, 30 days later, the event was considered resolved.This event was original reported under legacy btg mfr report #3002124543-2021-00014.The following information was received after the initial report was sent.On (b)(6) 2020, 89 days post therasphere administration, the subject developed ascites possibly due to progressive disease.The event was treated with puncture (3 times) and medically treated with spironolactone 75 mg and furosemide 60 mg.The physician noted the event to be not related to the administration procedure.At the time of reporting, the event was considered not recovered.No further information is known at this time.This report will be updated should additional information become available.
 
Event Description
It was reported that abdominal pain occurred.In (b)(6) 2020, subject (b)(6) subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was in the right hepatic artery (irrespective of origin) (segmentsv/vi/vii/viii).7.30 gbq was administered to the liver (right liver) through vial 1.9 days post treatment with therasphere, the subject presented with abdominal pain.In (b)(6) 2020, 25 days later, the subject was hospitalized in other institution for further evaluation and treatment.As a treatment, the subject was prescribed with lovenox, oxynorm bro 5 mg and innohep 18000 u.5 days later, the subject was discharged from hospital.In (b)(6) 2020, 30 days later, the event was considered resolved.This event was original reported under legacy btg mfr report #3002124543-2021-00014.The following information was received after the initial report was sent.On (b)(6) 2020, 89 days post therasphere administration, the subject developed ascites possibly due to progressive disease.The event was treated with puncture (3 times) and medically treated with spironolactone 75 mg and furosemide 60 mg.The physician noted the event to be not related to the administration procedure.At the time of reporting, the event was considered not recovered.No further information is known at this time.This report will be updated should additional information become available.Additional information was received that updated the onset from 15-dec-2020 to 25-nov-2020 (69 days) post-therasphere administration.The doses to perfused liver was 243.1 gy and dose to perfused tumor was 262.1 gy.
 
Manufacturer Narrative
This event was original reported under legacy btg mfr report #3002124543-2021-00014.This follow up report is being sent to capture additional information that has been received.
 
Manufacturer Narrative
This event was original reported under legacy btg mfr report #3002124543-2021-00014.This follow up report is being sent to capture additional information that has been received.(b)(4).
 
Event Description
It was reported that abdominal pain occurred.In (b)(6) 2020, subject (b)(6) subject was enrolled into the proactif study and the treatment with therasphere was performed on the same day.Type of therasphere infusion was in the right hepatic artery (irrespective of origin) (segmentsv/vi/vii/viii).7.30 gbq was administered to the liver (right liver) through vial 1.9 days post treatment with therasphere, the subject presented with abdominal pain.In (b)(6) 2020, 25 days later, the subject was hospitalized in other institution for further evaluation and treatment.As a treatment, the subject was prescribed with lovenox, oxynorm bro 5 mg and innohep 18000 u.5 days later, the subject was discharged from hospital.In (b)(6) 2020, 30 days later, the event was considered resolved.This event was original reported under legacy btg mfr report #3002124543-2021-00014.The following information was received after the initial report was sent.On (b)(6) 2020, 89 days post therasphere administration, the subject developed ascites possibly due to progressive disease.The event was treated with puncture (3 times) and medically treated with spironolactone 75 mg and furosemide 60 mg.The physician noted the event to be not related to the administration procedure.At the time of reporting, the event was considered not recovered.No further information is known at this time.This report will be updated should additional information become available.Additional information was received that updated the onset from 15-dec-2020 to 25-nov-2020 (69 days) post-therasphere administration.The doses to perfused liver was 243.1 gy and dose to perfused tumor was 262.1 gy.Additional information was again received that clarified the initial pain with an onset date of 26-sept-2020 (9 days post-therasphere treatment).The pain was further described as abdominal pain related to an extension of portal thrombosis and not ascites.
 
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Brand Name
THERASPHERE Y-90 GLASS MICROSPHERES
Type of Device
MICROSPHERES RADIONUCLIDE
Manufacturer (Section D)
BIOCOMPATIBLES UK LTD
weydon lane, farnham
weydon lane
surrey GU9 8 QL
UK  GU9 8QL
Manufacturer (Section G)
BIOCOMPATIBLES UK LIMITED
weydon lane, farnham
weydon lane
surrey GU9 8 QL
UK   GU9 8QL
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key12110169
MDR Text Key259744155
Report Number2134265-2021-08323
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/25/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
Patient SexMale
Patient Weight113 KG
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