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

Model Number UNKNOWN

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

Patient Problem Sepsis (2067)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

The events were reported through a retrospective clinical trial.Btg medical assessment: patient is a subject enrolled in the (b)(6) study: male (b)(6), white, hcc diagnosed (b)(6) 2015 with radiology, one nodule in segment viii, albumin 30g/l, afp 1835 ng/ml, child a6 bclc a.First therasphere® administration (b)(6) 2015: patient was diagnosed with sepsis (b)(6) 2015 and (approximately 10 days after treatment)approximately 10 days after treatment, he was admitted to an outside hospital in (b)(6) for fatigue, weakness and concern over infection with sirs physiology.He received a course of antibiotics and was discharged with a home nurse as well as occupational therapy.At the follow up visit (b)(6) 2016, hematology tests were within the limits of normal an afp has decrease to 21 ng/ml.Conclusion: syndrome that combines fatigue and fever, in accordance with diagnosis of systemic inflammatory response syndrome (sirs).This is an inflammatory state affecting the whole body in response to an infectious or non infectious insult.Antibiotics were provided, however the occurrence of an infection was not documented, event = sirs + proven of probable infection = sepsis, severity grade 3, serious ae, which lead to hospitalization and medical intervention, anticipated ae, related to therasphere® administration.No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed.If additional information becomes available, a follow up report will be submitted.No other information is available that could confirm/deny the alleged event.Sepsis is an anticipated adverse event as per the ifu/risk management documentation.At this time this report is considered final.

Event Description

Subject (b)(6) is an (b)(6) white male patient enrolled in the (b)(6) study.Medical history of: alcohol abuse; cirrhosis; diabetes; (b)(6); smoker; other - fissure anal; barret oesophagus; meningitis; arthritis.Hcc diagnosed on (b)(6) 2015, one nodule in segment viii, therasphere® administered (b)(6) 2015, total administered activity gbq 1.8572, lung shunt fraction 7.54%.Patient was diagnosed with sepsis (b)(6) 2015 and (approximately 10 days after treatment) patient was admitted to an outside hospital in for fatigue, weakness and concern over infection with sirs physiology.He received a course of antibiotics and was discharged with a home nurse as well as occupational therapy.He tells me that he suffered severe fatigue, which has improved but certainly not resolved by today.Patient was discharged (b)(6) 2015.Outcome: resolved.The events were not reported to btg by the investigator in 2015.

• Brand Name: THERASPHERE
• Type of Device: 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
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cente; 300 conshohocken state road; west conshohocken,, PA 19428-2998 ; 6103311537
• MDR Report Key: 8487620
• MDR Text Key: 141064365
• Report Number: 3002124543-2019-00031
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR