MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

Model Number	3.5GBQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Weakness (2145)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Btg medical assessment: "physisian" reported: following therasphere y90 treatment patient experienced a hemo-peritoneum that required a hepatic artery embolization.The first 3 days after treatment they felt fine but then got admitted to another hospital with weakness.Patient is stable now.Treatment date: (b)(6) 2019.Patient was administered 3.58 gbq of therasphere "radiation segmentectomy" right lobe sub-segment (dominant mass).On work up nuclear scan 8% lung shunting fraction.Date of event: (b)(6) 2019.Patient was admitted in a tertiary site; the purpose of admission is not known.Patient underwent angiography by outside providers on (b)(6) 2019 and they performed gel-foam embolization of the right hepatic artery sub-segment(s).The patient was transferred to uci where he underwent another right hepatic arterial gel-foam embolization on (b)(6) 2019.Hgbs stable since then.Patient was in to see physician (b)(6) 2019 and is doing fine with hgb stable.It is likely that the patient experiences a tumour bleeding.This hypothesis is supported by the treatment provided (hepatic artery embolization) the following information is needed to accurately assess (we will request from the "reporte"): tumor etiology, tumor size, tumor precise location, existence of bleeding diathesis, issue during the therasphere administration procedure, was the tumor deeply necrotic before treatment administration? what was the absorbed dose to the tumor? no device malfunction was reported.Btg medical assessment based on information received to date: hemo-peritoneum: severity 3; serious; causality: possibly tumour/likely device; expected.Tumor bleeding: severity 3; serious; causality: possibly tumour/likely device; expected.No batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (devices remain implanted in the patient.Information will be requested.No product malfunction/deficiency has been identified or reported.No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.
Event or Problem Description
Physician reported: following therasphere y90 treatment patient experienced a hemo-peritoneum that required a hepatic artery embolization.The first 3 days after treatment they felt fine but then got admitted to another hospital with weakness.Patient is stable now.Additional information received: 11-dec-2019.Treatment date: (b)(6) 2019.Date of event: (b)(6) 2019.Dose administered/location etc: 3.58 gbq "radiation segmentectomy" right lobe sub-segment (dominant mass).On work up nuclear scan 8% lung shunting fraction.Patient underwent angiography by outside providers on 11/29/19 and they performed gel-foam embolization of the right hepatic artery sub-segment(s).The patient was transferred to uci where he underwent another right hepatic arterial gel-foam embolization on (b)(6) 2019.Hgbs stable since then.Patient was in to see physician (b)(6) 2019 and is doing fine with hgb stable.Hemorrage is an anticipated adverse event listed in the ifu/risk management documentation.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 9466039
• Report Number: 3002124543-2019-00070
• Device Sequence Number: 2159639
• Product Code: NAW
• UDI-Device Identifier: 05060116920345
• UDI-Public: 05060116920345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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: Health Professional
• Device Model Number: 3.5GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/13/2019
• 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: Required Intervention