MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; NONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Encephalopathy (1833); Peritonitis (2252); Ascites (2596)

Event Type  Other  

Manufacturer Narrative

Case comment: peritonitis bacterial, ascites, encephalopathy are considered unlisted as per current therasphere instructions for use.There is not enough information to assess if the reported events were related or not to the use of therasphere but the company considers that the role of therasphere cannot be ruled out.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.Journal: hepatology, author: philip hilgard, mania hamami, amr el fouly, andre scherag, stefan muller, judith ertle, till heusner, vito r.Cicinnati, andreas paul, andreas bockisch, guido gerken and gerald antoch, title: radioembolization with yttrium-90 glasse microspheres in hepatocellular carcinoma: european experience safety and long-term survival, year: 2010 pages: 1741-1749.The device has not been sent to the manufacturer for eval.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.

Event Description

Spontaneous bacterial peritonitis [peritonitis bacterial]; grade 1-2 ascites [ascites]; encephalopathy [hepatic encephalopathy].Case description: initial information received on 16-jun-2015, combined with additional information received on 18-jun-2015: this literature case report was published in the journal hepatology by hilgard p.Et al, with the title "radioembolization with yttrium-90 glasse microspheres in hepatocellular carcinoma: european experience safety and long-term survival".It concerned a patient of unknown age and gender treated with radioembolization with y -90 glass microspheres (the rasp here) for hepatocellular carcinoma (hcc).Patient's medical history and concomitant medications were not reported.This patient was part of a study of 108 patients with child-pugh a orb disease and hcc treated with radioembolization with yttrium-90 microspheres (therasphere).Patients were routinely staged by a 3-phase computed tomography (ct) or magnetic resonance imaging (mri) of the liver, a contrast-enhanced ultrasound to further determine vascularity, as well as a ct of the lungs.In addition, all patients received a whole body and a single photon emission (spect-) ct scan after injection of tc-99 macroaggregated albumin (tc99-maa) into the hepatic artery for detection of radiation distributed to the lungs and/ or visceral organs.On an unspecified date the patient underwent radioembolization with yttrium-90 microspheres (therasphere) for hcc.No information on dose administered or lot number was provided.During the first month after therapy the patient developed clinical signs of hepatic decompensation with ascites (grade 1-2) and encephalopathy and showed a spontaneous bacterial peritonitis, which was controlled by antibiotic therapy.The outcome of the events was not provided.The author did not assess the relationship between the events experienced by the patient and therasphere.Upon review, the company assessed the case as serious (medically significant) and related to therasphere.

Manufacturer Narrative

The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.

Event Description

Spontaneous bacterial peritonitis [peritonitis bacterial].Grade 1-2 ascites [ascites].Encephalopathy [hepatic encephalopathy].Case description: initial information received on 16-jun-2015, combined with additional information received on 18-jun-2015: this literature case report was published in the journal hepatology by hilgard p.Et al, with the title "radioembolization with yttrium-90 glasse microspheres in hepatocellular carcinoma: european experience safety and long-term survival".It concerned a patient of unknown age and gender treated with radiembolization with y-90 glass microspheres (therasphere) for hepatocellular carcinoma (hcc).Patient's medical history and concomitant medications were not reported.This patient was part of a study of 108 patients with child-pugh a or b disease and hcc treated with radioembolization with yttrium-90 microspheres (therasphere).Patients were routinely staged by a 3-phase computed tomography (ct) or magnetic resonance imaging (mri) of the liver, a contrast-enhanced ultrasound to further determine vascularity, as well as a ct of the lungs.In addition, all patients received a whole body and a single photon emission (spect-) ct scan after injection of tc-99 macroaggregated albumin (tc99-maa) into the hepatic artery for detection of radiation distributed to the lungs and/ or visceral organs.On an unspecified date the patient underwent radioembolization with yttrium-90 microspheres (therasphere) for hcc.No information on dose administered or lot number was provided.During the first month after therapy the patient developed clinical signs of hepatic decompensation with ascites (grade 1-2) and encephalopathy and showed a spontaneous bacterial peritonitis, which was controlled by antibiotic therapy.The outcome of the events was not provided.The author did not assess the relationship between the events experienced by the patient and therasphere.Upon review, the company assessed the case as serious (medically significant) and related to therasphere.Final assessment on 11-mar-2016: no device failure has been identified as a result of this adverse events.Follow up information was requested to further investigate the event; the reporter informed that no further information on the case could be provided.It has been assessed that no corrective action is necessary at this time and the report is final.Case comment: peritonitis bacterial, ascites, encephalopathy are considered unlisted as per current therasphere instructions for use.There is not enough information to assess if the reported events were related or not to the use of therasphere but the company considers that the role of therasphere cannot be ruled out.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: NONE
• 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; ste 200; ottawa, ontario K2K 2-X1
• MDR Report Key: 4898201
• MDR Text Key: 24671005
• Report Number: 3002124545-2015-00041
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2016
• 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