MAUDE Adverse Event Report: BIOCOMPATIBLE UK LTD. THERASPHERE®

Lot Number 1799023/37

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

Patient Problems Internal Organ Perforation (1987); No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  Injury  

Event Description

This report, (b)(4) subject (b)(6), last sae report: (b)(6) 2018, sae: gastric perforation (gastric perforation) this report concerns subject (b)(6), a female subject (b)(6) who was enrolled in study (b)(6) entitled "a (b)(6) clinical trial evaluating therasphere® in subjects with metastatic colorectal carcinoma of the liver who have failed first line chemotherapy".Although, the information regarding subject randomization was not reported on the sae report form, it was confirmed that the patient was randomized to therasphere® study device group.The subject received therasphere® 107 gy to the right lobe and 121 gy and 115 gy to the left lobe on (b)(6) 2017.Information regarding treatment with second-line chemotherapy for metastatic colorectal carcinoma was not provided.The subject's medical history was not reported at the time of this report.On (b)(6) 2018, the subject was hospitalized due to gastric perforation, grade 3.The subject treatment was not reported at the time of this report.The event gastric perforation outcome was not reported at the time of this report.The subject continued participation in the study.The investigator assessed the event of gastric perforation as grade-3 (severe) in intensity, serious criterion was reported at the time of this report.The event was assessed as possibly related to study device (to selective internal radiation therapy sirt procedure), not related to study procedure and to second line chemotherapy.The company assessed the event of gastric perforation as unlikely related to study device, not related to study procedure and to second line chemotherapy.A supplemental report will be submitted if additional relevant information is received.Three (3) therasphere vials were used to treat this patient, it cannot be determined which device contributed to the serious injury.Refer to mdr 3002124543-2018-00007 and 3002124543-2018-00013 for the other devices associated with this event.

Event Description

This is a follow-up report to update that this sae (gastric perforation) has been downgraded by the investigator and determined to be not related to the study device.Therefore it is not reportable as an emdr event.Event problem code has been updated to reflect this change.Mfr # 3002124543-2018-00012.(b)(4).Subject number: (b)(6).Last sae report: (b)(6) 2018.3 therasphere vials were used to treat this patient.Refer to mdr 3002124543-2018-00007 and 3002124543-2018-00013 for the other devices used to treat this patient.A supplemental report is not planned to be submitted if additional information is received, unless the event will be re-assessed as related to therasphere® either by the investigator or by the company.

• 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: 7288229
• MDR Text Key: 100652500
• Report Number: 3002124543-2018-00012
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920307
• UDI-Public: 05060116920307
• 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
• Report Date: 03/08/2018

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: 03/31/2017
• Device Lot Number: 1799023/37
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REFER TO PREVIOUS REPORT
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Weight: 67