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

Model Number 1.79GBQ

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Btg medical assessment: on the (b)(6) 2019, patient was treated with 1.79gbq of therasphere administered in the left liver via femoral artery.Patient was hospitalised for digestive hemorrhage (start (b)(6) 2019, stop (b)(6) 2019) and has been treated by sandostatine, prophylactic antibiotherapy and elastic on oesophagus varices.Investigator listed causality of the sae as concurrent disease and confirmed the event not to be related to the administration procedure or therasphere® device action taken: surgery or interventional radiology procedure and concomitant medication.At baseline patient is to be classified bclc c, multifocal tumor and alteration of liver function.The event occurred 5 weeks after therasphere administration in a patient that has liver cirrhosis.It is likely that therasphere treatment has led to the increase of preexisting portal hypertension, and caused the upper gi hemorrhage it is of note that the patient received a treatment even the presence of "warning", child b8, elevated bilirubin, this patient was at high risk of disease decompensation.Hemorrhage is an anticipated adverse event listed in the study protocol/risk management documentation.Severity grade 4; serious: yes, patient was hospitalised; anticipated; related: device possibly increased pre existing portal hypertension.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 datatrak site # (b)(4), subject number: 250015-002, (b)(6) 2019.Subject number: 250015-002 male patient born in 1956, (b)(6).Main comorbidities; alcohol intake history and tobacco intake history.Disease characteristics: liver cirrhosis related to alcohol.Tumour type: hcc diagnosed (b)(6) 2017, multifocal tumour in the right and left liver.Patient has received prior anti-cancer treatments, loco regional liver treatment and liver surgery.The loco regional liver treatment has been listed as ablation: not document i if it was rfa, microwave, or cryo.The patient required liver resection and the liver segment that was removed.Pre treatment biology: bilirubin 44 micro mol/l, albumin 27gr/l, asl 3xuln child pugh score b8, bclcc and ecog not measured, on the (b)(6) 2019, patient was treated with 1.79gbq of therasphere administered in the left liver via femoral artery.Patient was hospitalised for digestive hemorrhage (start (b)(6) 2019, stop (b)(6) 2019) and has been treated by sandostatine, prophylactic antibiotherapy and elastic on oesophagus varices.Investigator listed causality of the sae as concurrent disease and confirmed the event not to be related to the administration procedure or therasphere® device action taken: surgery or interventional radiology procedure and concomitant medication.

• 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: 9238695
• MDR Text Key: 167155502
• Report Number: 3002124543-2019-00062
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1.79GBQ
• 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: 09/25/2019
• 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
• Patient Age: 63 YR