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 Abdominal Pain (1685); Hemorrhage/Bleeding (1888)

Event Date 04/28/2019

Event Type  Injury  

Manufacturer Narrative

Btg medical assessment: the patient had pre-existing portal hyper tension and was taking anticoagulation.It is possible that therasphere treatment had transitory increased portal hypertension leading to pre-existing variceal bleeding.Anticoagulation treatment might have favoured this event.Melena: grade 3; serious - led to hospitalisation; anticipated; possibly related device; resolved without sequelae.Rectal bleeding: grade 3; serious - led to hospitalisation; anticipated; possibly related device; resolved without sequelae.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)(6) 19-mar-2020 for this patient enrolled on the (b)(6) study.Therasphere treatment date: (b)(6) 2019.Total administered: 0.77 gbq via femoral artery.Volume of total perfused liver 282 cm^3.Sae start date: (b)(6) 2019.Gi hemorrhage and rectal bleeding required hospitalization (b)(6) 2019.Discharge date: (b)(6) 2019.Outcome: resolved.Reported as possibly related to therasphere device and administration procedure.Other causality: concurrent disease (digestive hemorrhages on varicose veins).Patient received one administration of therasphere® on (b)(6) 2019, 0.77 gbq in the left femoral artery.On (b)(6) 2019, the patient was hospitalised with melena and rectal bleeding (4 times of abundant rectal bleeding without clots).This led to a serious deterioration in health and required in-patient hospitalisation or prolongation of existing hospitalisation.On the (b)(6) 2019, epigastric pain in the night lasting 4hrs without irradiation.Occurrence of 2 melenas in the morning (lasting 8hrs).At hospital, normal clinical examination, no pain.Improving thrombocytopenia, scanner thorax abdomen and pelvis: no active bleeding, lack of scalability of transjugular intrahepatic portosystemic shunt (tips) level.The patient was discharged on the (b)(6) 2019.The investigator has listed the causality probably related to the administration procedure, to the device and digestive hemorrhages on varicose veins.Action taken: concomitant medication and stop anticoagulation at 2 months of treatment.The reported events are known adverse events listed in the ifu/risk management documentation.The events were not reported to btg/bsc in 2019.

• 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, surrey ; UK
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cntr; 300 conshohocken state road; west conshohocken, pa ; 3311537
• MDR Report Key: 9956481
• MDR Text Key: 198531061
• Report Number: 3002124543-2020-00008
• 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
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• 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: 03/19/2020
• 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: 47 YR
• Patient Weight: 92