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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD. THERASPHERE®

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BIOCOMPATIBLES UK LTD. THERASPHERE® Back to Search Results
Lot Number 1799044
Device Problems Unexpected Therapeutic Results (1631); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Cancer (3262)
Event Date 04/26/2017
Event Type  Injury  
Event Description
Mfr report number: 3002124543-2017-00025.(b)(4).Subject (b)(6).Last sae report: 19 may 2017.Sae: hepatic necrosis (hepatic necrosis).This report concerns subject (b)(6), a (b)(6) male, who was enrolled in the study (b)(6) entitled "a phase iii clinical trial evaluating therasphere® in subjects with metastatic colorectal carcinoma of the liver who have failed first line chemotherapy".On (b)(6) 2017, the subject received the first treatment with study device therasphere® with dosage of 117 gy to the right lobe and 120 gy to the left lobe.The subject started treatment with second-line chemotherapy for metastatic colorectal carcinoma; capox regimen (oxaliplatin 280 mg iv, capecitabine 2000 mg oral) on (b)(6) 2017.On (b)(6) 2017 subject received third cycle of second-line chemotherapy, capox regimen (oxaliplatin 280 mg iv and capecitabine 2000 mg oral).The subject's relevant medical history included nausea, diarrhea, constipation and abdominal pain.The subject`s concomitant medication included omeprazole (oral 20 mg, od), loperamide 2 mg (oral, prn), codeine (oral 15 mg, qds) and laxido (oral 125 ml, prn).On (b)(6) 2017, the subject experienced adverse event of hepatic necrosis and was hospitalized.Laboratory results on (b)(6) 2017 included: increased bilirubin values 92 ¿m/l (normal range 0-21), on (b)(6) 2017- 71¿m/l (normal range 0-21), on (b)(6) 2017- 63 ¿m/l (normal range 0-21).Ct liver scan was performed on the same day.It showed new cystic liver lesion centrally in the right lobe, which is suspected due to liver necrosis and a bile leak.It was also found 2 aneurysms in common hepatic artery.Thought to be mycotic cause.Subject was treated with antibiotics.Drainage of liver abscess was scheduled on (b)(6) 2017.On (b)(6) 2017 the event of hepatic necrosis was resolved with sequelae and the subject was discharged from the hospital.Co-amoxiclav was recommended to be continued after discharge from the hospital until next outpatient ct scan review.The subject continued participation in the study.The investigator assessed the event of hepatic necrosis as grade 4 (life-threatening) in intensity and serious due to hospitalization.The event was considered as definitely related to study device.The event was not related to study procedure, standard of care sorafenib and pre-existing condition.The company agreed with investigator's assessment.A supplemental report will be submitted if additional relevant information is received.
 
Event Description
This follow-up report is being sent to correct pma/510(k) number to h980006.
 
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Brand Name
THERASPHERE®
Type of Device
THERASPHERE®
Manufacturer (Section D)
BIOCOMPATIBLES UK LTD.
chapman house farnham business
weydon lane
farnham, surrey GU9 8 QL
UK  GU9 8QL
Manufacturer Contact
sandra bausback-aballo
chapman house farnham business
weydon lane
farnham, surrey GU9 8-QL
UK   GU9 8QL
MDR Report Key6594184
MDR Text Key76062437
Report Number3002124543-2017-00025
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
H980006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation Physician
Remedial Action Patient Monitoring
Type of Report Initial,Followup
Report Date 04/27/2017
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 Physician
Device Expiration Date02/24/2017
Device Lot Number1799044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Initial Date Manufacturer Received 04/27/2017
Initial Date FDA Received05/26/2017
Supplement Dates Manufacturer Received04/27/2017
Supplement Dates FDA Received11/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CAPECITABINE; CODEINE; LAXIDO; LOPERAMIDE; OMEPRAZOLE; OXALIPLATIN
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age58 YR
Patient Weight90
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