MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number 990700.SPE

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

Patient Problems Encephalopathy (1833); Hemorrhage/Bleeding (1888); Hyperbilirubinemia (1903); Ascites (2596)

Event Date 08/01/2020

Event Type  Death  

Manufacturer Narrative

Medical assessment concurred with the assessment that the ascites, hyperbilirubinemia, rectal bleeding and encephalopathy were all related to the therasphere procedure.Encephalopathy, hyperbilirubinemia, ascites, bleeding and death are potential adverse events that are listed in the ifu.

Event Description

Patient (b)(6) with a solitary nodule in the left liver received therasphere on (b)(6) 2019.The absorbed dose to the liver was 122gy.The patient presented with dark rectal bleeding (grade 4) on the (b)(6) 2020 and was hospitalized on (b)(6) 2020.The patient developed an encephalopathic coma secondary to the digestive hemorrhage, which was exacerbated by hypovolemia occuring during diuretic treatment.This was attributed to the ectopic varicous veins of the small intestine.The patient emerged from the coma on (b)(6) 2020 with no further recurrence of bleeding, and the event resolved on (b)(6) 2020.This event was assessed as probably related to the therasphere procedure.The patient received treatment for rectal bleeding, and again presented with hepatic encephalopathy on (b)(6) 2020, along with ascites (grade 4) and hyperbilirubinemia (grade 4).Profuse ascitic decompensation was also observed, with all adverse events attributed to the evolution of the hepatic disease.The subject did not recover from the coma and died on the (b)(6) 2020.The physician reported that the encephalopathy, rectal bleeding, ascites and hyperbilirubinemia were probably related to the therasphere procedure.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• 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: 10659524
• MDR Text Key: 210989919
• Report Number: 3002124543-2020-00020
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920284
• UDI-Public: 05060116920284
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990700.SPE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 48 YR