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

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

Patient Problems Death (1802); Liver Damage/Dysfunction (1954)

Event Type  Death  

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

Liver toxicity of grade 3 or higher (liver decompensation with abundant ascites) [hepatic failure].Two patients died of disease progression [disease progression].The remaining 3 were still alive with recurrence [recurrent cancer].Case description: initial information received on 11-may-2015 (initially assessed as non-valid, this case was re-assessed as valid and reopened for submission): this spontaneous literature medical device report was published in the journal of nuclear medicine by garin, e.Et al, with the title "personalized dosimetry with intensification using 90y-loaded glass microsphere radioembolization induces prolonged overall survival in hepatocellular carcinoma patients with portal vein thrombosis", concerning 4 patients of unknown age or gender.The patients' medical history included hepatic carcinoma with portal vein thrombosis (pvt).The patients' concomitant medications were not provided.On an unspecified date, between oct-2008 and sep-2012, 41 patients were treated with a personalized dosimetric approach of 90y-loaded glass microsphere injections (therasphere) (lot numbers and expiration dates not reported) for hepatic carcinoma with portal vein thrombosis (pvt).The microspheres were administered according to current standard guidelines.After diagnostic angiography, liver perfusion scanning was conducted and then 185 mbq of 99mtc-maa were injected in the hepatic artery.After 8 to 15 days, therasphere was injected, using a lobar approach.In cases of bilateral disease, 2 lobar treatments were administered separately, with a 6 to 8 week interval between treatments.Five patients were exhibiting good response and complete portal vein revascularization, including one with main pvt, underwent wide hepatectomy.Complete resection (ro) was achieved for all patients, although residual tumoral areas were revealed on microscopic examination in all patient tumors and in the portal veins of two.On an unknown date, at the time of evaluation, 2 patients died of disease progression [disease progression] and the remaining 3 were still alive with recurrence [recurrent cancer].On an unknown date, four patients presented with clinically relevant and permanent liver toxicity of grade 3 or higher (liver decompensation with abundant ascites) [hepatic failure].The decompensation began within 6 weeks, worsening until inducing death in all 4 patients.Each had a child-pugh score of a5 at baseline, transaminases lower than 5-fold normal value, and normal bilirubin values, with the exception of 1 patient with a value of 34 microm/ml.All 4 patients exhibited a poor 99mtc-maa targeting of the pvt (3 main, 1 branch).Pvt was the only tested parameter that was associated with liver toxicity on univariate analysis.The authors assessed that one explanation to the event could be that radioembolization induced transient portal hypertension, which could be poorly tolerated by pvt patients who presented with poor liver function and no accurate treatment of pvt because of the absence of targeting.They also reported that patients with main pvt were often considered poor candidates for radioembolization and that the procedure might be considered contraindicated in these cases.The company considered the events liver failure and disease progression as serious (fatal) and the event recurrent cancer as non-serious.After multiple attempt of follow up to obtained further information, the case is considered lost to follow-up and the report final.Case comment: hepatic failure was considered anticipated according to current therasphere instructions for use, whilst disease progression and recurrent cancer were unanticipated.There was not enough information to assess if the liver toxicity was related to the use of therasphere but the company considered that the role of therasphere in the reported event (liver failure) cannot be ruled out.The use of radioactivity and the previous condition of the patients could also have had an impact on the fatal outcome of the patients.The events of disease progression as well as recurrent cancer were related to the unfortunate course of the disease and not related to the theraspere treatment.As mentioned by the authors, therasphere is contraindicated for patients with severe liver dysfunction.

• 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, GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL
• MDR Report Key: 7142616
• MDR Text Key: 95670649
• Report Number: 3002124543-2017-00048
• Device Sequence Number: 1
• Product Code: NAW
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2015
• 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