MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD. THERASPHERE®

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.

• 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 Key: 6594184
• MDR Text Key: 76062437
• Report Number: 3002124543-2017-00025
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• 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 Date: 02/24/2017
• Device Lot Number: 1799044
• 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 Received: 05/26/2017
• Supplement Dates Manufacturer Received: 04/27/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CAPECITABINE; CODEINE; LAXIDO; LOPERAMIDE; OMEPRAZOLE; OXALIPLATIN
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Weight: 90