MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; SINGLE USE IMPLANTABLE MEDICAL DEVICE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Fall (1848); Liver Damage/Dysfunction (1954); Hip Fracture (2349)

Event Date 01/01/2016

Event Type  Death  

Event Description

Unsuccessful treatment of her hcc [device ineffective].Lesions in left lobe had grown in size/ there were lesions in her right lobe [hepatic lesion].Medical complications related to fall and hip fracture.Liver failure [hepatic failure].Fall.Case description: initial information received on 19-jan-2017: this spontaneous medical device report was received from a consumer via company representative concerning a (b)(6) female patient.The patient's medical history included: initial dose of y-90 shunted to gastric artery; ast and alt increased; total bilirubin and alpha fetoprotein increased; and albumin decreased.Concomitant medications included: ibuprofen, multivitamin, calcium/vitamin d (calcium carbonate, cholecalciferol); medrol dosepak (methylprednisolone); protonix (pantoprazole sodium sesquihydrate); reglan (metoclopramide hydrochloride); and zofran (ondansetron hydrochloride).The patient received therasphere (yttrium-90 glass microspheres) initially on (b)(6) 2016 for hepatocellular carcinoma.The patient was then treated with therasphere 3 gbq once via a catheter on (b)(6) 2016 to the left hepatic artery and 8 gbq once via a catheter on (b)(6) 2016 to the right hepatic lobe for hepatocellular carcinoma.Lot numbers and expiration dates were not provided.Upon recovering from initial y-90 treatment on (b)(6) 2016, the lesions in the patient's left lobe had grown in size as well as there were lesions in her right lobe.The patient was treated again with therasphere (y-90) to the left hepatic artery and to her right hepatic lobe.Both treatments were tolerated well, but neither proved effective in slowing or eliminating the tumors.On an unspecified date, the patient experienced liver failure; and fell and fractured her hip.On (b)(6) 2017, the patient passed away following unsuccessful treatment of her hcc.The cause of death was determined to be likely a combination of liver failure and medical complications related to a fall and hip fracture.The reporter assessed the events as serious.The company assessed the events of liver failure and medical complications related to a fall and hip fracture as serious (fatal) and the events of unsuccessful treatment of her hcc and lesions in left lobe had grown in size/ there were lesions in her right lobe as medically significant.Follow-up information is being requested.This case is linked to case (b)(4), originating from the same patient.Case comment: device ineffective, hip fracture and hepatic lesion are considered unlisted according to the therasphere current reference safety information whereas hepatic failure and fall are listed.In agreement with the reporter, the company considers the event of device ineffective as related to the treatment with therasphere.In absence of the reporter's assessment, the company considers the events of hepatic failure and hepatic lesions as related to the treatment with therasphere as the devices failure to treat the patient's underlying hepatocellular carcinoma possibly lead to the patient's disease progression/advancement, the hepatic failure and death.In absence of the reporter's assessment and due to a lack of information, the company considers the events of fall and hip fracture as related to therasphere as these events cannot be excluded.This single case report does not modify the risk benefit balance of therasphere.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Event Description

Unsuccessful treatment of her hcc [device ineffective].Lesions in left lobe had grown in size/ there were lesions in her right lobe.Medical complications related to fall and hip fracture.Liver failure [hepatic failure].Fall.Case description: initial information received on 19-jan-2017: this spontaneous medical device report was received from a consumer via company representative concerning a (b)(6) female patient.The patient's medical history included: initial dose of y-90 shunted to gastric artery; ast and alt increased; total bilirubin and alpha fetoprotein increased; and albumin decreased.Concomitant medications included: ibuprofen, multivitamin, calcium/vitamin d (calcium carbonate, cholecalciferol); medrol dosepak (methylprednisolone); protonix (pantoprazole sodium sesquihydrate); reglan (metoclopramide hydrochloride); and zofran (ondansetron hydrochloride).The patient received therasphere (yttrium-90 glass microspheres) initially on (b)(6) 2016 for hepatocellular carcinoma.The patient was then treated with therasphere 3 gbq once via a catheter on (b)(6) 2016 to the left hepatic artery and 8 gbq once via a catheter on (b)(6) 2016 to the right hepatic lobe for hepatocellular carcinoma.Lot numbers and expiration dates were not provided.Upon recovering from initial y-90 treatment on (b)(6) 2016, the lesions in the patient's left lobe had grown in size as well as there were lesions in her right lobe.The patient was treated again with therasphere (y-90) to the left hepatic artery and to her right hepatic lobe.Both treatments were tolerated well, but neither proved effective in slowing or eliminating the tumors.On an unspecified date, the patient experienced liver failure; and fell and fractured her hip.On (b)(6) 2017, the patient passed away following unsuccessful treatment of her hcc.The cause of death was determined to be likely a combination of liver failure and medical complications related to a fall and hip fracture.The reporter assessed the events as serious.The company assessed the events of liver failure and medical complications related to a fall and hip fracture as serious (fatal) and the events of unsuccessful treatment of her hcc and lesions in left lobe had grown in size/ there were lesions in her right lobe as medically significant.Follow-up information is being requested.Follow-up information received on (b)(6) 2017 from the clinical research coordinator: liver magnetic resonance imaging (mri) was conducted on (b)(6) 2016 with following impression provided: cirrhosis and evidence of portal hypertension.Multiple large treated hcc's in segments 3 and 8 with areas of irregular and nodular rim enhancement concerning for residual tumor.One lesion in segment 8 was associated with portal vein tumor thrombosis.Worsening of liver function was diagnosed.The patient received therasphere on (b)(6) 2016 (lot number 0002280714) and on (b)(6) 2016 (lot number 0002303162).The patient had fallen on (b)(6) 2017 and was admitted to the emergency room for assessment.The patient was admitted to hospice re-habilitation center to care for broken hip and the legal representative reported on (b)(6) 2017 that things were not looking good and she did not think that the patient would make it to the clinic visit scheduled on (b)(6) 2017.The patient reported the following lab results: on (b)(6) 2016, alpha fetoprotein was at 5850.1.On (b)(6) 2016, alpha fetoprotein was at 15574.4.On (b)(6) 2016, alpha fetoprotein was at 1363.2.On (b)(6) 2017, bilirubin was at 2.8, albumin at 2.4 and alpha fetoprotein at 1787.1.The reporter stated that the event worsening of liver function may have been due to the therasphere treatment, whereas the fractured hip was considered unrelated to treatment with therasphere.Follow-up information will be requested for medical confirmation.This case is linked to (b)(4), originating from the same patient.Case comment: device ineffective, hip fracture and hepatic lesion are considered unlisted according to the therasphere current reference safety information whereas hepatic failure and fall are listed.In agreement with the reporter, the company considers the event of device ineffective as related to the treatment with therasphere.In absence of the reporter's assessment, the company considers the events of hepatic failure and hepatic lesions as related to the treatment with therasphere as the devices failure to treat the patient's underlying hepatocellular carcinoma possibly lead to the patient's disease progression/advancement, the hepatic failure and death.In absence of the reporter's assessment and due to a lack of information, the company considers the events of fall and hip fracture as related to therasphere as these events cannot be excluded.This single case report does not modify the risk benefit balance of therasphere.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

• Brand Name: THERASPHERE
• Type of Device: SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: 11 hines road, suite 200; ottawa, ontario K2K 2-X1
• MDR Report Key: 6300121
• MDR Text Key: 66468252
• Report Number: 3002124545-2017-00006
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2017
• 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
• Treatment: CALCIUM W/VITAMIN D (CALCIUM CARBONATE); IBUPROFEN (IBUPROFEN); MEDROL (METHYLPREDNISOLONE); MULTIVITAMIN (VITAMINS NOS) TABLET; PROTONIX (PANTOPRAZOLE SODIUM SESQUIHYDRATE); REGLAN (METOCLOPRAMIDE HYDROCHLORIDE); ZOFRAN (ONDANSETRON HYDROCHLORIDE)
• Patient Outcome(s): Death; Other
• Patient Age: 77 YR
• Patient Weight: 62