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

Model Number 2.79GBQ

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

Patient Problems Abdominal Pain (1685); Death (1802); Fatigue (1849); Pneumonia (2011); Sepsis (2067); No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

The events were reported through a retrospective clinical trial.The events are considered serious due to hospitalization and reported to be related to therasphere procedure, however while the patient was admitted to the hospital with fatigue, the fatigue was not treated with medical or surgical intervention to prevent permanent damage to a body structure or function.Patient subsequently died.Btg medical assessment: the patient bclc c, child a5, was received the 1st treated with therasphere: (b)(6) 2017.Total administered activity: 2.79 gbq, in the liver, segment ii, vii, viii hepatic artery branches.On (b)(6) 2017, the patient underwent shoulder arthroplasty and was admitted locally on (b)(6) 2017 due to fatigue and anorexia.On (b)(6) 2017, admitted to site with worsening shortness of breath and blood-streaked sputum, persistent shoulder pain and abdominal pain.Patient was initially found to have decompensated copd w/ acute exacerbation, and pneumonitis vs pneumonia.He underwent thorough work-ups and managed accordingly.Abdominal pain was initially thought to be probably related to y90 treatment, but egd showed candidal esophagitis, and pud was ruled out.Patient`s condition deteriorated as he developed worsening pneumonia and severe sepsis.No encephalopathy neither ascites were noted.The patient died (b)(6) 2017.There was no device failure or malfunction.In conclusion concomitant disease = shoulder arthroplasty.Following this procedure, the patient presented with shortness of breath, pneumonia, fungus infection of the gi tract, causing abdominal pain and anorexia.The bacteria at the origin of the sepsis, stenotrophomonas maltophilia.Could it be a consequence of a infection contacted while in the hospital for arthroplasty fatigue likely due to concomitant disease and possibly to therasphere treatment.Adverse events: fatigue: severity grade 4; serious; concomitant disease and device - lead to hospitalization; anticipated, anorexia: severity grade 4; non-serious; secondary to fatigue and candida albicans gi tract infection.Pain abdominal: severity grade 4; non-serious; related gi tract infection; anticipated, pneumonia and sepsis; serious; concomitant disease - lead to death; anticipated (infection).The events were not reported to btg in 2017.Further follow up with the reporter was performed and despite the patient's concomitant medical condition, the reporter could not rule out that fatigue was possibly related to the therasphere procedure which resulted in hospitalization, consequently btg are reporting this event with an abundance of caution.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.At this time this report is considered final.

Event Description

Auto-notifications received from (b)(4) 01-aug-2019 as follows: subject: (b)(6) is a (b)(6) year-old male, white, patient.Diagnosed with hcc: (b)(6) 2007.No presence of portal hypertension.Liver fibrosis.Bclc classification: c.Hcc etiology: non alcoholic steatohepatitis.1st treated with therasphere: (b)(6) 2017.Total administered activity: 2.79 gbq in the liver, segment ii, vii, viii hepatic artery branches.Lung shunt fraction: 3.89%.On (b)(6) 2017 patient presented with fatigue and admitted to local hospital - ongoing.On (b)(6) 2017 patient presented with anorexia and admitted to local hospital - ongoing.No encephalopathy neither ascites were noted.On (b)(6) 2017 patient presented with abdominal pain leading to hospitalization - (patient admitted and being managed by primary team) - ongoing.Patient was reported to have died: (b)(6) 2017 (causality not reported).The events were not reported to btg in 2017.Additional information received: 06-aug-2019: this patient passed away at home on (b)(6) 2017.He was discharged from the hospital on (b)(6) 2017 to home hospice.To summarize, pt underwent therasphere treatment on (b)(6) 2017, which was uneventful.On (b)(6) 2017, pt underwent shoulder arthroplasty and was admitted locally on (b)(6) due to fatigue and anorexia.On (b)(6), admitted to site with worsening shortness of breath and blood-streaked sputum, persistent shoulder pain and abdominal pain.Pt was initially found to have decompensated copd w/ acute exacerbation, and pneumonitis vs pneumonia.Underwent thorough work-ups and managed accordingly.Abdominal pain was initially thought to be probably related to y90 treatment, but egd showed candidal esophagitis, and pud was ruled out.Patient`s condition deteriorated as he developed worsening pneumonia and severe sepsis.Pt was eventually discharged to home hospice on (b)(6) 2017 and passed away on (b)(6) 2017.Additional information received: 12-aug-2019: reporter provided the following assessment: "in cases of post-y90 treatment, almost always, fatigue was attributed as possibly related as it is hard to rule it out completely even with other etiologies.Usual other cause is concomitant disease, which is the malignancy.In this specific case, "shoulder arthroplasty" is the procedure, which was performed due to persistent pain secondary to prior shoulder injury.Regarding infection, bacteria identified was from sputum, stenotrophomonas maltophila, as mentioned in my initial email, which could be iatrogenic.Bactrim was started and other antibiotics discontinued when results came out, which was supposed to be until (b)(6), but patient passed (b)(6).Candidal esophagitis was noted to have been treated prior to discharge.By then, patient`s liver function started deteriorating, with poor prognosis, and eventually discharged to home hospice.

Event Description

Additional information received: 24-aug-2019.As a follow-up on the case: dr.Mahvash returned from his leave and we received final information on patient (b)(6)."regarding pt (b)(6): fatigue was determined to be unrelated to therasphere.It was attributed to concomitant combination of disease and other complications.

Manufacturer Narrative

Updated btg medical assessment: 30-aug-2019.The patient (b)(6), was received the 1st treated with therasphere: (b)(6) 2017 total administered activity: 2.79 gbq, in the liver, segment ii, vii, viii hepatic artery branches.On (b)(6) 2017, the patient underwent shoulder arthroplasty and was admitted locally on (b)(6) 2017 due to fatigue and anorexia.On (b)(6) 2017, admitted to site with worsening shortness of breath and blood-streaked sputum, persistent shoulder pain and abdominal pain.Pt was initially found to have decompensated copd w/ acute exacerbation, and pneumonitis vs pneumonia.He underwent thorough work-ups and managed accordingly.Abdominal pain was initially thought to be probably related to y90 treatment, but egd showed candidal esophagitis, and pud was ruled out.Patient`s condition deteriorated as he developed worsening pneumonia and severe sepsis.No encephalopathy neither ascites were noted.The patient died the (b)(6) 2017.There was no device failure or malfunction.Summary: hcc treated with therasphere: on (b)(6) 2017.Total administered activity: 2.79 gbq, in the liver, segment ii, vii, viii hepatic artery branches.On (b)(6) 2017, concomitant disease = shoulder arthroplasty.Following this procedure, the patient presented with shortness of breath, pneumonia, fungus infection with candida albicancs of the gi tract, causing abdominal pain and anorexia.Fatigue likely due to concomitant disease.Sepsis, infection with stenotrophomonas maltophilia.That could it be a consequence of an infection contacted while in the hospital for arthroplasty.Adverse events: fatigue: severity grade 4; serious; concomitant disease and device lead to hospitalization; anticipated.Anorexia: severity grade 4; non-serious; secondary to fatigue and candida albicans gi tract infection; pain abdominal: severity grade 4; non-serious; related gi tract infection; anticipated pneumonia and sepsis; serious; concomitant disease lead to death; anticipated (infection) the events were not reported to btg in 2017.Confirmation was received from the reporting physician that fatigue was not considered to be related to the administration of therasphere; anorexia was still reported to be related to therasphere, but assessed by btg medic as secondary to fatigue and candida albicans gi tract infection.All other events i.E.Abdominal pain, penumonia and sepsis were unrelated to therasphere administration (concomitant disease).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.No other information is available that could confirm/deny the alleged event.At this time this report is considered final.

• 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, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 8891885
• MDR Text Key: 154242648
• Report Number: 3002124543-2019-00053
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2.79GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 70 YR