MAUDE Adverse Event Report: BIOCOMPATIBLE UK LTD. THERASPHERE®

Lot Number	1799020/34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr # 3002124543-2018-00013.(b)(4).(b)(6).Last sae report: 01 feb 2018.Sae: gastric perforation (gastric perforation).This report concerns (b)(6), a female subject (b)(6), who was enrolled in (b)(6).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 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 3002124543-2018-00012 for the other devices associated with this event.
Event or Problem 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 # 3002124543-2018-00013.(b)(4).Subject number: (b)(6).Last sae report: (b)(6) 2018.Three therasphere vials were used to treat this patient.Refer to mdr 3002124543-2018-00007 and 3002124543-2018-00012 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®
• Common Device Name: THERASPHERE®
• Manufacturer (Section D): BIOCOMPATIBLE UK LTD.; chapman house farnham business; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 7288236
• Report Number: 3002124543-2018-00013
• Device Sequence Number: 1993788
• Product Code: NAW
• UDI-Device Identifier: 05060116920376
• UDI-Public: 05060116920376
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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
• Operator of Device: Physician
• Device Expiration Date: 03/31/2017
• Device Lot Number: 1799020/34
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Weight: 67