MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number	10 GBQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulcer (2274)
Date of Event	06/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device malfunction was reported.The device met all release criteria.Gastric ulcer is an anticipated event associated with extra hepatic deposition of microspheres into the stomach.The cause of the stomach ulcer could not be determined due to the limited information reported.Follow up attempts have been made to obtain additional information, but to date no additional information has been received.If additional information is reported, a follow up report will be submitted.
Event or Problem Description
On 15 june 2018, it was reported that a male patient was treated with therasphere on (b)(6) 2018 (right lobe treatment) without issue.A second therasphere treatment on (b)(6) 2018 was administered to the patient's left lobe (1110 cc volume, 133 gy, 10gbq treatment, 13% lung shunt fraction).The patient was admitted to the hospital following the second treatment (date unknown) for hematemesis and coffee ground stools.It was confirmed on egd that the patient had a gastric ulcer.The patient was discharged from the hospital on (b)(6) 2018.The duration of hospitalization and treatment provided to the patient was not reported.
Additional Manufacturer Narrative
No device malfunction was reported.The device met all release criteria.Based on the additional information received, there was no evidence of extra hepatic deposition of therasphere in the stomach, therefore the event is to be considered not related to the device.
Event or Problem Description
This is a follow up submission to report additional information received from the physician and to update the conclusion.This 60 year old male patient with a history of hcc, ascites, hep c, copd, esophageal varices, encephalopathy, portal hypertension, hepatorenal syndrome, coronary artery disease, diabetes, thrombocytopenia was treated with therasphere to the right lobe on (b)(6) 2018 (dose not reported) followed by another treatment to the left lobe on (b)(6) 2018 (1110 cc volume, 133 gy, first week 10gbq treatment, 13% lsf).This patient's comorbidities include copd, morbid obesity, cirrhosis, hep c, and diabetes.There was no coiling done pre-treatment and no extra hepatic deposition of maa was noted during pre-treatment.Following the therasphere treatment on (b)(6) 2018, there was no evidence of microspheres in the stomach.The patient developed hematemesis and coffee ground stools and was hospitalized on (b)(6) 2018.The patient underwent a egd which demonstrated large antral ulceration, shallow with no stigmata of gi bleed.While hospitalized the patient received prbc transfusion.The ulcer resolved and the patient was discharged on (b)(6) 2018.The physician states he does not know whether this was related to the therasphere treatment or not.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 7686823
• Report Number: 3002124543-2018-00041
• Device Sequence Number: 13624210
• Product Code: NAW
• UDI-Device Identifier: 05060116920314
• UDI-Public: 05060116920314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: Health Professional
• Device Model Number: 10 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: 1899225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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; Required Intervention
• Patient Age: 60 YR