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

Model Number 20-30 MICROMETERS

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Encephalopathy (1833); Fatigue (1849); Inflammation (1932); Liver Damage/Dysfunction (1954); Nausea (1970); Ulcer (2274); Ascites (2596)

Event Type  Injury  

Event Description

Gastric ulcer [gastric ulcer].Ascites [ascites].Cholecystitis [cholecystitis].Hepatic encephalopathy [hepatic encephalopathy].Hepatic failure [hepatic failure].Pleural effusion [pleural effusion].Nausea [nausea].Fatigue [fatigue].Abdominal pain [abdominal pain].Case description: initial information received on 30-mar-2017: this medical device report was received from a literature article by kallini jr.Et al.Entitled "comparison of the adverse event profile of therasphere with sir-spheres for the treatment of unresectable hepatocellular carcinoma: a systematic review" published in the cardiovascular and interventional radiology journal regarding adult male and female patients (mean age not reported).Between 01-jan-2004 and 24-apr-2014, observational studies, randomized controlled clinical trials, and non-randomized clinical trials, published in english, were considered eligible for inclusion in this systematic review.Thirty one studies were considered in this review, 22 investigating therasphere.Baseline characteristics and adverse events of all grades related to gastrointestinal, hepatobiliary, and respiratory systems were collected along with commonly reported outcomes related to post-embolization syndrome.For all outcomes, data from each study were collected for each intervention.The patients' medical history included unresectable hepatocellular carcinoma (hcc).The patients' concomitant drugs were not reported.On an unspecified date, between 01-jan-2004 and 24-apr-2014, 1597 patients were treated with therasphere (size: 20-30 microm; lot numbers and expiration dates were not reported) for unresectable hcc.Therasphere had an activity of 2500 bq per sphere at calibration and the maximal activity vial of 20 gbq contained 8 million spheres.No contrast agent was used or needed during the infusion.Across all studies, 1065 (88%) lobar administrations and 142 (12%) segmental administrations of glass microspheres (therasphere) took place.On an unspecified date, between 01-jan-2004 and 24-apr-2014, several adverse events from all grades were experienced by the patients.0.1% of the patients experienced gastric ulcers and 9.2% of the patients experienced ascites.Cholecystitis and hepatic encephalopathy were experienced by 1.5% and 3.9% of the patients, respectively.Hepatic failure was reported in 6.9% of the patients.Symptoms associated with post-embolization syndrome like nausea, fatigue and abdominal pain were experienced by 17.9%, 47.9% and 19.8% of the patients, respectively.Data about biochemical adverse events were also gathered: decreased serum platelet count (25.0%), albumin (55.3%) and lymphocytes and increased alkaline phosphatase (29.7%), alt, ast, serum bilirubin (41.2%), creatinine (6.9%) and prothrombin (53.5%).For adverse events that were grade 3 or higher, 0.1% of the patients treated with therasphere developed gastric ulcers.The reported percentage of grade 3 ascites was higher with glass microsphere treatment: 6.1% (25/411) patients in patients treated with glass microspheres (therasphere).Cholecystitis and hepatic encephalopathy grade 3 or higher as an ae were experienced by 1.9% and 2.8% of the patients, respectively.Pleural effusion, grade 3 or higher, was reported in 0.9% of the patients.Grade 3 or higher symptoms associated with post-embolization syndrome like nausea, fatigue and abdominal pain were experienced by 1.5%, 1.9% and 1.9% of the patients, respectively.Additionally, grade 3 or higher decrease in platelet count, alt, increased prothrombin and increased bilirubin were experienced by 3.7%, 3.6%, 2.7% and 19.0% of the patients.No patients had grade 3 or higher increased creatinine.The outcome of all the events was not reported.The reporter classified the events in 2 groups: all grades events and grade 3 or higher events.The reporter considered all the events related to therasphere.The company considered the events post-embolization syndrome, gastric ulcer, ascites, cholecystitis, hepatic encephalopathy, hepatic failure and pleural effusion as serious.No further information is expected as this was a systemic review of articles.This case is final.Company comment: gastric ulcer, ascites, cholecystitis, hepatic encephalopathy, hepatic failure, pleural effusion, nausea, fatigue and abdominal pain are considered anticipated according to therasphere current reference safety information.In line with the assessment made by the reporter, the company considered that the events gastric ulcer, ascites, cholecystitis, hepatic encephalopathy, hepatic failure and pleural effusion are related to the use of therasphere.Therasphere does not have an embolizing effect, however some of the events associated with post embolization syndrome i.E.Nausea, fatigue and abdominal pain are related to therasphere.The elevated liver enzymes indicates degrees of hepatic damage and is a consequence of radioembolization.There is no report of device failure or malfunction, and therasphere performed as expected.The article does not report on any medical or surgical intervention was performed in response to any of the listed adverse events, therefore it is unclear if they were serious injuries.In an abundance of caution, the company is reporting these events due to lack of information.

• 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; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback ; lakeview, riverside way; watchmoor park; camberley, surrey GU15 -3YL ; UK GU15 3YL ; 61033
• MDR Report Key: 6529550
• MDR Text Key: 73941214
• Report Number: 3002124543-2017-00018
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20-30 MICROMETERS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• 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
• Patient Outcome(s): Other