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 Problems Death (1802); Hyperbilirubinemia (1903); Liver Damage/Dysfunction (1954); Ascites (2596); Test Result (2695)

Event Date 09/21/2017

Event Type  Death  

Manufacturer Narrative

The events were reported through a retrospective clinical trial.The events are considered serious and related to therasphere administration and possibly to patient disease progression.Btg medical assessment: subject (b)(6) is a (b)(6) male patient.Diagnosed with hcc on an unknown date in (b)(6) 2017.Etiologic associations: liver cirrhosis related to alcohol abuse.Ongoing (b)(6) and diabetes.No prior sorafenib treatment or disease specific surgery prior to therasphere® treatment.Baseline bclc: stage c.Biochemistry and tumour marker - bilirubin 0.70, albumine 41g/l, afp 75ng/ml, ggt 260ui/l.Hcc in the right liver lobe, 120mm largest diameter, one tumor.Therasphere® treatment: (b)(6) 2017.Activity at start of infusion: 5.56gbq.Residual in delivery set 0.013gbq.Lung shunt fraction 3.2%.Target lesion: right liver lobe, treated volume 79% of total liver volume.Dose to the perfused liver: 125gy.Dose to whole liver: 90gy.Concomitant medications: pantoprazole 20 mg ((b)(6) 2017).Tramadol 100mg/ml ((b)(6) 2017).Paracetamol 1000 mg ((b)(6) 2017).The patient developed ascites (grade 1) (b)(6) 2017; aspartate aminotransferase increased (grade 3) (b)(6) 2017; 206ui/l, bilirubin creased (grade 3) (b)(6) 2017; 3.3 mg/l, gamma glutamyl transferase increased (grade 3) (b)(6) 2017 - 495ui/l.All non-serious events.On (b)(6) 2017 the patient experienced hepatic failure (grade 4) resulting in death (grade 5 ).The reporter assessed the event of hepatic failure as related to therasphere treatment.Conclusion: hepatic failure, related to therasphere® administration in a patient with a huge tumor dose to the tumor was within the recommended dose so that an "overdosing" could not be responsible of the event.Serious adverse events, anticipated events associated with therasphere procedure listed in the risk management documentation.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-notification received from (b)(4) 08-may-2019.Subject (b)(6) is a (b)(6) male patient enrolled on the (b)(6) study.Diagnosed with hcc on an unknown date in (b)(6) 2017.Etiologic associations: liver cirrhosis related to alcohol abuse.Ongoing (b)(6) and diabetes.No prior sorafenib treatment or disease specific surgery prior to therasphere® treatment.Baseline bclc: stage c.Biochemistry and tumour marker - bilirubin 0.70, albumine 41g/l, afp 75ng/ml, ggt 260ui/l.Hcc in the right liver lobe, 120mm largest diameter, one tumor.Therasphere® treatment: (b)(6) 2017.Activity at start of infusion: 5.56gbq.Residual in delivery set 0.013gbq.Lung shunt fraction 3.2%.Target lesion: right liver lobe, treated volume 79% of total liver volume.Dose to the perfused liver: 125gy.Dose to whole liver: 90gy.Concomitant medications: pantoprazole 20 mg ((b)(6) 2017).Tramadol 100mg/ml ((b)(6) 2017).Paracetamol 1000 mg ((b)(6) 2017).The patient developed ascites (grade 1) (b)(6) 2017; aspartate aminotransferase increased (grade 3) (b)(6) 2017; 206ui/l, bilirubin creased (grade 3) (b)(6) 2017; 3.3 mg/l, gamma glutamyl transferase increased (grade 3) (b)(6) 2017 - 495ui/l.All non-serious events.On (b)(6) 2017 the patient experienced hepatic failure (grade 4) resulting in death (grade 5).The reporter assessed the event of hepatic failure as related to therasphere treatment.The events were not reported to btg by the investigator in 2017.

• 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
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, 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: 8594948
• MDR Text Key: 144560071
• Report Number: 3002124543-2019-00039
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• 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: 05/08/2019
• 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): Death
• Patient Age: 63 YR