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

Model Number	4 GBQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Liver Damage/Dysfunction (1954); Renal Failure (2041)
Date of Event	12/24/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Limited information was reported.Follow up attempts have been made and minimal information has been provided.It is unlikely to suspect therasphere to be the cause of the events.Post therasphere administration imaging and dose to the lungs is important information that is unknown.Lung shunt fraction of 18.5% is quite high, therefore the dose to the lung is a key element.A massive therasphere deposition to the lung could cause radiation pneumonitis, although the development of radiation pneumopathy within this time period (3 days) is rare.The etiology of kidney failure remains unknown at this time.Outstanding follow up information has been requested.Based on the limited information available, it is unlikely that therasphere is the cause of the reported events, but therasphere as a contributing factor could not be ruled out.No device malfunction was reported.If additional information is received, a follow up report will be submitted.
Event or Problem Description
Limited information was reported that a male patient was prescribed 120 gy of therasphere to treat primary hcc, with cholangiocarcinoma in right lobe.The lung shunt fraction was 18.5%.The patient received 120.7 gy of therasphere to the liver on (b)(6) 2018 and developed bilateral airspace disease (suspected radiation pneumonitis) 3 days post treatment on (b)(6) 2018.The physician reported that it became more interstitial and they treated the patient with steroids assuming this was radiation pneumonitis.It was also reported that the patient experienced kidney failure.It is unknown at this time if renal insufficiency was a preexisting condition.The patient died on (b)(6) 2019, 13 days after therasphere treatment.
Additional Manufacturer Narrative
This is a follow up mdr to report the results of the device history review.A batch history review was performed by bwxt on 29 jan 2019 for lot 1899576.The review confirmed that all aspects of batch 1899576 met all acceptance criteria and no issues were reported during the batch manufacturing.No additional information is expected at this time, but if additional information is reported, a follow up report will be submitted.
Event or Problem Description
This is a follow up mdr to report the results of the device history review.Refer to initial mdr for event description.
Additional Manufacturer Narrative
Additional information received 15-mar-2019.Btg follow up medical assessment comments: additional information reported that this patient was prescribed 120 gy of therasphere to treat primary hcc, with cholangiocarcinoma in right lobe.The lung shunt fraction was 18.5%.The patient received 120.7gy of therasphere to the liver and developed bilateral airspace (suspected radiation pneumonitis) disease 3 days post treatment.The patient was treated with steroids.It was also reported that the patient experienced kidney failure.This patient died on (b)(6) 2019, 13 days after therasphere treatment.The complementary information allowed to rule out other etiologies, and the histological data are compatible with acute phase of radiation, even not specific radiation pneumonitis: serious adverse event; anticipated; likely related to device kidney failure resulting in death: serious adverse event; anticitipated; unlikely related to device.
Event or Problem Description
Limited information was reported that a male patient was prescribed 120 gy of therasphere to treat primary hcc, with cholangoicarcinoma in right lobe.The lung shunt fraction was 18.5%.The patient received 120.7gy of therasphere to the liver on (b)(6) 2018 and developed bilateral airspace disease (suspected radiation pneumonitis) 3 days post treatment on (b)(6) 2018.The physician reported that it became more interstitial and they treated the patient with steroids assuming this was radiation pneumonitis.It was also reported that the patient experienced kidney failure.It is unknown at this time if renal insufficiency was a preexisting condition.The patient died on (b)(6) 2019, 13 days after therasphere treatment.

• 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, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 8284499
• Report Number: 3002124543-2019-00004
• Device Sequence Number: 1953195
• Product Code: NAW
• UDI-Device Identifier: 05060116920352
• UDI-Public: 05060116920352
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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: 4 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: 1899576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 03/15/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/04/2019; 04/05/2019
• 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: Death; Hospitalization; Other
• Patient Age: 85 YR