MAUDE Adverse Event Report: BIOCOMPATIBLE UK LTD. THERASPHERE®

Lot Number 1699220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Liver Damage/Dysfunction (1954); Radiation Exposure, Unintended (3164)

Event Date 11/28/2016

Event Type  Injury  

Event Description

(related to mfr # 3002124543-2018-00008 and 3002124543-2018-00015).This subject received 3 therasphere treatments, it cannot be determined which device contributed to the serious injury.Internal mcn: (b)(4).Subject number: (b)(4).Last significant sae report: (b)(6) 2018.Sae: radiation induced liver damage (radiation hepatitis).This report concerns subject (b)(4), a female subject born in (b)(6), who was enrolled in study ts-102 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) 2015, the subject started treatment with second-line chemotherapy for metastatic colorectal carcinoma; folfiri regimen (irinotecan, fluorouracil and folinic acid).On (b)(6) 2016, the subject received sixth cycle of second-line chemotherapy, folfiri regimen (irinotecan 180 mg/m^2 iv, fluorouracil 400 mg/m^2 iv and 2400 mg/m^2 iv infusion and folinic acid 350 mg iv).On (b)(6) 2015, as per the e-crf the subject received therasphere® 120 gy to the right and left hepatic lobes.On (b)(6) 2016, the subject received therasphere® 100 gy to the right hepatic lobe and on (b)(6) 2016, the subject received therasphere® 100 gy to the left hepatic lobe.The subject's medical history included hypertension and diabetes type 2.The subject's concomitant medication included lansoprazole, atenolol and spironolactone.On (b)(6) 2016, the subject was experiencing adverse events leg edema grade 2 and low albumin grade-3, which were deteriorating over the week and the subject was hospitalized on the same date with diagnosis of radiation induced liver damage.On (b)(6) 2016, the ct scan performed revealed a slight increase of liver metastasis.Leg edema and low albumin did not improve, condition of the subject progressively worsened, abdominal edema and also type 2 diabetes were diagnosed, which required continuation of hospitalization.On (b)(6) 2016, the subject had not recovered from the event of radiation induced liver damage and died on the same day with to hepatic failure due to disease progression.The subject continued participation in the study.The investigator assessed the event of radiation induced liver damage as grade-4 (life-threatening) in intensity, serious due to hospitalization and life-threatening, possibly related to study device and also related to disease under study.The event was assessed as unrelated to study procedure and to second line chemotherapy.The company assessed the event of radiation induced liver damage as probably related to study device, unrelated to study procedure and to second line chemotherapy.A supplemental report will be submitted if additional relevant information is received.

Event Description

This is a follow-up report to correct the event resolution date (date of death).Mfr # 3002124543-2018-00014.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: 15 may 2018.Sae: radiation induced liver damage (radiation hepatitis).Radiation induced liver damage is considered ended on 16 dec 2016 due to subject death.3 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the serious injury.Refer to mdr# 3002124543-2018-00015 and 3002124543-2018-00008 for other devices associated with this event.A supplemental report will be submitted if additional relevant information is received.

Event Description

This is a follow-up report to update outcomes attributed to adverse event (death removed), device received dosage and treatment area, relevant tests/laboratory data, date of tests, type of reportable event, remedial action initiated, investigator's assessment, event problem codes.Internal mcn: (b)(4).Subject number: (b)(4).Last sae report: 20 mar 2018.Sae: radiation induced liver damage (radiation hepatitis).The subject received initial therasphere® treatment 120 gy to both right and left hepatic lobes on (b)(6) 2015.On (b)(6) 2016, ct (computed tomography) scan (thorax, abdomen and pelvis) was performed, which showed new intra-hepatic duct dilation likely to be secondary to diffuse/infiltrative metastatic disease in liver at the porta hepatis.There was evidence of pulmonary metastasis and increasing bony destruction and new moderate volume right sided pleural and ascetic fluid.Ct scan also revealed that the liver texture appeared abnormal; consistent with radiation-induced liver damage.The investigator assessed that the event of radiation induced liver damage resulted in persistent/significant disability or incapacity.The company agreed with the investigator's update.3 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the serious injury.Refer to mdr# 3002124543-2018-00015 and 3002124543-2018-00008 for other devices associated with this event.A supplemental report will be submitted if additional relevant information is received.

Event Description

This is a follow-up report to update hospitalization information and subject final outcome.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: 01 may 2018.Sae: radiation induced liver damage (radiation hepatitis).Hospitalization for radiation induced liver damage is considered as ended and the event is considered as resolved on (b)(6) 2016 due to subject death.3 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the serious injury.Refer to mdr# 3002124543-2018-00015 and 3002124543-2018-00008 for other devices associated with this event.A supplemental report will be submitted if additional relevant information is received.

• Brand Name: THERASPHERE®
• Type of Device: THERASPHERE®
• Manufacturer (Section D): BIOCOMPATIBLE UK LTD.; chapman house farnham business; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 7288279
• MDR Text Key: 100642961
• Report Number: 3002124543-2018-00014
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920338
• UDI-Public: 05060116920338
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/12/2016
• Device Lot Number: 1699220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATENOLOL.; LANSOPRAZOLE.; METFORMIN.; SPIRONOLACTONE.; ATENOLOL; LANSOPRAZOLE; METFORMIN; SPIRONOLACTONE
• Patient Outcome(s): Death; Hospitalization; Disability
• Patient Age: 73 YR
• Patient Weight: 108