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); Fever (1858)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

The events were reported through a retrospective clinical trial.The events are considered serious and possibly related to therasphere (reporting investigator), related to patient condition (btg medical assessment).Btg medical assessment: 60 year-old male was treated with therasphere® in (b)(6) 2017 and again in (b)(6) 2017 due to residual/recurrent disease.Had been experiencing abdominal pain for several days and per phone call with physician on (b)(6) 2017 was instructed to take prevacid or prilosec.Ultimately went to er and was admitted to hospital.Per edc: "telephone encounter on (b)(6) 2017: spoke with patients wife.Patient was at (b)(6) for one night for abdominal pain and fever and home now feeling better.He did have bilat ultrasound of groins report reads bilateral common femoral arteries widely patent.There is no sonographic evidence of pseudoaneurysm or hematoma in either groin." hospital admission (b)(6) 2017.No ongoing complaints noted at (b)(6) 2017 follow up visit.Limited information available other than details in the follow up office note as the patient was treated for this event at an outside facility.Btg is unable to assess if the medical intervention was taken to prevent a permanent damage to a body structure or function based on the information provided.Abdominal pain: serious; severity 3; related (resolved with adapted treatment) fever: serious; severity 3; related.Abdominal pain and fever are anticipated adverse events listed in the ifu/risk management documentation.The events were not reported to btg in 2017.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 datatrak 29-jul-2019 as follows: subject: (b)(6) is a 60 year-old male, white, patient enrolled on the retrospective (b)(6) study.Diagnosed with hcc: (b)(6) 2017.Hcc etiology: hepatitis c, solitary lesion at location viii, bclc classification: c (ecog 1).Total liver volume 1123 (ml).Future remnant liver volume 466 (ml).1st treated with therasphere: (b)(6) 2017.1 vial administered - total administered activity: 0.974 gbq.Total volume of perfused liver: 326 (cm3).Volume of treated lobe: 657 (cm3).2nd therasphere treatment: (b)(6) 2017.Lung shunt fraction 2.9%.1 vial administered - total administered activity: 0.771.Whole liver volume: 1358 (cm3).Total volume of perfused liver: 289 (cm3).Volume of treated lobe: 776 (cm3).On 09-oct-2017 patient experienced fever and abdominal pain which lead to overnight hospitalization (b)(6) 2017.They had a bilateral ultrasound of groins and the report reads "bilateral common femoral arteries widely patent.There is no sonographic evidence of pseudoaneurysm or hematoma in either groin".Patient was discharged (b)(6) 2017.Outcome: resolved (b)(6) 2017.Fever: sae.Severity grade 3.Unrelated to procedure.Possibly related to therasphere.Abdominal pain: sae.Severity grade 3.Unrelated to procedure.Possibly related to therasphere.

• 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: 8868289
• MDR Text Key: 154460934
• Report Number: 3002124543-2019-00055
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• 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: 07/29/2019
• 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; Required Intervention
• Patient Age: 60 YR