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 Problem Tissue Damage (2104)

Event Date 07/13/2011

Event Type  Injury  

Manufacturer Narrative

The events were reported through a retrospective clinical trial.The events are considered serious and probably related to the therasphere administration.Btg medical assessment: subject (b)(6) is (b)(6) year old male patient enrolled in the (b)(6) study, hcc diagnosed in (b)(6) 2011 with underlying alcoholic cirrhosis; before treatment in (b)(6) 2011, the medical condition and cancer staging were as followed: portal hypertension on the presence of splenomegaly and low white blood count (3.4) and low platelet count (105), slight anemia (11.7gr/dl).Liver test profile normal, slight bilirubin elevation 1.4 mg/l, coagulation test, normal, child pugh a5, ecog 0, left liver lobe lesion 40mm x 40mm by mri.Baseline bclc stage: a.Patient did not receive sorafenib prior to therasphere treatment nor any disease specific surgery.(b)(6) 2011.The patient was administered therasphere to the left lobe activity ordered 13gbq, 1.238gbq was administered to the patient.The lung "shung" fraction was "4.!%".(b)(6) 2011.The patient experienced arterial injury (no more documentation).Action taken: endarterectomy on (b)(6) 2011.Took tylenol without relief.(dose, duration not documented).(b)(6) 2011.Patient recovered.Arterial injury: severity grade 3.Serious: required additional procedure/medication.Anticipated adverse event.Related to arterial procedure.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.Arterial injury (tissue damage) is an anticipated adverse event as per the ifu/risk management documentation.At this time, this report is considered final.

Event Description

Auto-notifications were received from (b)(4) on 01-mar-2019.Subject (b)(6) is (b)(6) year old male patient enrolled in the (b)(6) study, hcc diagnosed in (b)(6) 2011 with underlying alcoholic cirrhosis portal hypertension on the presence of splenomegaly and low white blood count (3.4) and low platelet count (105), slight anemia (11.7gr/dl) (b)(6) 2011.Liver test profile normal, slight bilirubin elevation 1.4 mg/l, child pugh a5, coagulation test, normal, ecog 0, patient did not receive sorafenib prior to therasphere treatment nor any disease specific surgery.Left liver lobe lesion 40mm x 40mm (b)(6) 2011 assessed by mri.Baseline bclc stage: a.The patient was administered therasphere to the left lobe on (b)(6) 2011.Activity ordered 13gbq, 1.238gbq was administered to the patient.The lung "shung" fraction was "4.!%." it was reported that the patient experienced arterial injury on (b)(6) 2011.The reporter assessed the event as an expected event related to the study treatment.Action taken: endarterectomy on (b)(6) 2011.Took tylenol without relief.It was reported that the patient recovered/event was resolved on (b)(6) 2011.The reporter assessed this event as serious due to endarterectomy performed.The event was not reported to btg by the treating physician at the time of the event in 2011.

• 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, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey 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: 8395326
• MDR Text Key: 138084082
• Report Number: 3002124543-2019-00024
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• 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: 03/01/2019
• 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): Required Intervention
• Patient Age: 80 YR