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

Model Number 3.18 GBQ

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

Patient Problem Ascites (2596)

Event Date 04/03/2012

Event Type  Injury  

Manufacturer Narrative

(b)(6) medical assessment comments: patient (b)(6), hepatits b liver cirrhosis.Medical history of pancytopenia (neutrophils, lymphocytes, red blood cells, platelets), hypoalbuminemia, hypocalcemia, and fatigue.Ecog 1 at baseline.Bclc c, presence of pvt and ascites grade 1, 88 mm tumor in the right liver, albumine 30 gr/l, afp> 4000 ui/ml.On the (b)(6) 2012 the patient received 3.18 gbq of therasphere.On the (b)(6) 2012, at a follow-up visit, ascites was grade 3, ecog was 1, hematology test were stable compared to baseline, albumin was 37g/l, bilirubin increase from 0.9 to 1.4 mg/l, afp had decreased to 39 ui/l tumor size decreased to 54 mm.On (b)(6) 2012, the ascites was noted grade 3 on the imaging evaluation with a decrease in size of the tumor to 36 mm.On (b)(6) 2012 the ascites was noted grade 3 on the imaging evaluation with a decrease in size of the tumor to 24 mm.On (b)(6) 2013 the ascites was noted grade 2 on the imaging evaluation with a tumor size of 28 mm.There is no documentation of procedure or medication provided for the treatment of ascites for the 1st occurrence.Aggravation of pre-existing portal hypertension with occurrence of ascites.There was no device failure or malfunction.Updated: 18-may-2020: ascites (1st occurrence)- (b)(6) 2012: severity grade 3; anticipated; non-serious; possibly related to device with aggravation of baseline portal hypertension.Ascites (2nd occurence - worsened) - (b)(6) 2012: severity grade 3; anticipated; serious; possibly related to device with aggravation of baseline portal hypertension.Ascites is a known inherent risk associated with sirt listed in the ifu/risk management documentation.No batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (device remains implanted in the patient).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 Description

Auto-notification received from (b)(6) 06-apr-2020 for this patient enrolled on the target clinical study.Subject is a (b)(6) white, male patient diagnosed with hcc (b)(6) 2012 presence of portal hypertension.Etiologic associations with hcc: liver cirrhosis, hepatitis b.No prior sorafenib treatment before therasphere treatment or prior surgery baseline bclc stage: c.Concomitant medication: on (b)(6) 2012 - acetaminophen-hydrocodone 5 mg.Medical history: on (b)(6) 2012: white blood cell count decreased.On (b)(6) 2012: anaemia.On (b)(6) 2012:thrombocytopenia.On (b)(6) 2012: lymphocyte count decreased.On (b)(6) 2012: hypocalcenia.On (b)(6) 2012: hypoalbuminemia.On (b)(6) 2012: fatigue grade 1.Therasphere treatment: on (b)(6) 2012: administered to right lobe activity recorded at start of treatment 3.21 gbq.Residuals remaining in delivery set 0.027 gbq.Total administered activity 3.18 gbq.Fraction of perfused liver 48.7%.Lung shunt fraction 10.1%.No device malfunction reported.A subject has reported a serious adverse event.Please see the following for more information.Site #: (b)(6), subject number: (b)(6), adverse event: ascites, start date: (b)(6) 2012, relationship to study treatment: possibly related.Additional information received 05-may-2020 and confirmed as an sae (b)(6) 2020: this patient had trace of ascites at baseline, was treated with therasphere on (b)(6) 2012 and had asymptomatic moderate ascites at his (b)(6) 2012 follow-ups.It then became a large amount of ascites on his (b)(6) 2012 visit (7 months post treatment) where he needed weekly paracentesis and was admitted for spontaneous bacterial peritonitis (sbp).It became serious outside the protocol time allowed to report an event within the clinical trial.Information captured for pms purposes.Ae start date (b)(6) 2012, sae start date: (b)(6) 2012.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW, PRODUCT
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey ; UK
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cntr; 300 conshohocken state road; west conshohocken, pa ; 3311537
• MDR Report Key: 10073744
• MDR Text Key: 200982604
• Report Number: 3002124543-2020-00015
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.18 GBQ
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR