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BIOCOMPATIBLES UK LTD LC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD
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| Model Number |
100 - 300 MICRON |
| Medical Device Problem Codes |
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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| Health Effect - Clinical Codes |
Anemia (1706); Death (1802); Diarrhea (1811); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Hiccups (1899); Hyperbilirubinemia (1903); Liver Damage/Dysfunction (1954); Nausea (1970); Pain (1994); Vomiting (2144); Sleep Dysfunction (2517); Ascites (2596); Weight Changes (2607); Test Result (2695); Constipation (3274)
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Type of Reportable Event
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Death
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Additional Manufacturer Narrative
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Btg medical assessment comments: this study is a prospective single-arm open-label phase ii two-stage trial, which aimed to enrol 51 adult liver transplant candidates with marginal hepatic reserve and liver limited hcc without vascular invasion or extracapsular - extension.Use of lc beads® loaded with drug is an off label use in u.S.They chose to include in this study patients with impaired liver function and liver function test but without regard to the usual contra indications for tace.Patients were required to have impaired hepatic reserve based on the selection criteria: presence of at least one of the following clinical evidence of ascites, serum bilirubin between 3 and 6 mg/dl, ast and/or alt level between 5 and 10 times upper normal limit, international normalized ratio for prothrombin time (inr) between 1.6 and 2.5 in the absence of ongoing anticoagulation therapy, main portal vein thrombosis, and functioning trans-jugular intrahepatic portosystemic shunt (tips) or surgical shunt.Patients with impaired functional status (eastern cooperative group performance status, ecog, worse than 2), impaired renal function (serum creatinine >1.5 mg/dl), macrovascular tumour invasion or extrahepatic disease, medically refractory hepatic encephalopathy, symptomatic heart disease, previous bile duct sphincterotomy or biliary-enteric anastomosis, and liver transplant recipients were excluded.Deb-tace was performed with up to two 2-ml vials of spherical polyvinyl alcohol microspheres (lc bead®) impregnated per standard manufacturer-supplied protocol with a total of 100 mg of reconstituted doxorubicin hydrochloride powder (25 mg per millilitre of beads; mylan, canonsburg, pa).Investigational device exemption (ide number (b)(4)) was obtained from the united states food and drug administration (fda) per the requirement of the irb.Microspheres in the size range of 100-300 microns were used.Primary study objectives were to determine the safety of deb-tace in accordance to nci ctcae and to determine the best observed overall radiographic response (orr) rate to deb-tace according to mrecist.Secondary objectives were to determine the proportion of patients who remained active on the wait list for a liver transplant and were eventually transplanted; adverse events (ae) were graded according to national cancer institute common terminology criteria for adverse events (nci ctcae) version 4.03.Clinical and laboratory evaluations were performed approximately 1, 7, and 30 days after each deb-tace procedure, and subsequently every 3 months for up to 1 year after last deb-tace procedure a total of 17 patients (median age 66 years, range 58-73 years; 13 men) were treated with at least 1 deb-tace procedure during the first stage of the study.Safety assessments clinical aes all patients experienced at least one ae as a result of the deb-tace procedures.Most common clinical aes were: self-limited grade 1 or 2 aes - fatigue, anorexia, nausea, abdominal pain, and insomnia, all of which resolved within 1 month of deb-tace.Four patients had worsening of lower extremity edema within one month of debtace resolved after supportive treatment and/or diuretics within one month of onset.2 patients with a decline in ecog performance that was transitory 13 patients had grade 3 or 4 ae attributed to deb-tace (76%).- seven patients (41%) developed symptoms of fluid retention.Three patients (18%) had worsening ascites, 2/3 requiring periodic large volume paracenteses, while one was successfully treated with diuretics.2 patients had developed severe (grade 3) leg edema, which was life-long and refractory to diuretics - six patients experienced irreversible decline in performance status.4 patients had hepatic failure grade 3 (defined in nci ctcae v 4.03 as asterixis, mild encephalopathy, and limited ability to perform activities of daily living) and was deemed unrelated to deb-tace for 2 patients.The fourth patient was found to have metastatic hcc to the brain and died 3 months after deb-tace.One patient died from liver failure 1.8 months following the first deb-tace, which may have been related to deb-tace.Laboratory aes a total of 16 patients (94%) experienced new or worsening laboratory ae within 1 month of deb-tace.Twelve patients (71%) developed new-onset grade 3 laboratory ae, hyponatremia (n=5), hyperbilirubinemia (n=3), ast elevation (n=3), thrombocytopenia (n=3), anaemia (n=2), and creatinine elevation (n=1).All grade 3 ae returned to baseline (majority within 30 days of deb-tace), except for 1 patient with hyperbilirubinemia that was attributed to an unplanned total hip arthroplasty performed 10 days following deb-tace and 1 patient with thrombocytopenia as well as grade 4 hyponatremia.Procedure-related mortality was 1 out of 17 (6%).There was no device failure or malfunction it is of note that the study was conducted in a population of patient that were in poor condition with clinically significant impairment of liver function at study entry.Adverse event assessment: decreased appetite: severity 1/2; non-serious; related to drug; anticipated with drug use ascites: severity 1/2; non-serious; related to device; anticipated ascites: severity 3; serious; related to device; anticipated constipation: severity 1; non-serious; not related to device; unanticipated diarrhoea: severity 1; non-serious; related to drug; anticipated with drug use dyspnoea: severity 1; non-serious; not related - concomitant disease; unanticipated oedema peripheral: severity 1/2; non-serious; degradation of liver function; anticipated oedema peripheral: severity 3; serious; degradation of liver function; anticipated fatigue: severity 1/2; non-serious; related to device; anticipated pyrexia: severity 1; non-serious; related to device; anticipated hepatic failure: severity 3; serious; related to device; anticipated hepatic failure: severity 3; serious; unrelated - disease progression; anticipated pain: severity 1/2; non-serious; related to device; anticipated pain: severity 3; serious; related to device; anticipated hiccups: grade 1/2; non-serious: related to device; unanticipated insomnia: severity 1/2; non-serious; not related device; unanticipated nausea: severity 1/2; non-serious; related to drug; anticipated anaemia: severity 1/2; non-serious; related to drug; unanticipated hyperbilirubinemia: severity 1/2; non-serious; related to device; anticipated hyperbilirubinemia: severity 3; serious; unrelated - concomitant disease; anticipated aspartate aminotransferase increased: severity 1/2; non-serious; related to device/drug; anticipated aspartate aminotransferase increased: severity 3; serious; related to device/drug; anticipated alanine aminotransferase increased: severity 1/2; non-serious; related to device/drug; anticipated blood alkaline phosphatase increased: severity 1/2; non-serious; related to device; anticipated hyponatremia: severity 3; non-serious; unrelated - concomitant medical condition cirrhosis; unanticipated leukopenia: severity 1/2; non-serious; related to drug; anticipated with drug use thrombocytopenia: severity 3; non-serious; degradation of liver function; unanticipated blood creatinine increased: severity 3; non-serious; degradation of liver function; unanticipated inr increased: severity 1/2; non-serious; degradation of liver function; unanticipated no device malfunction was reported and no corrective and preventive action (capa) plan has been identified.The lot number of the associated devices is unknown, therefore no investigation could be performed.If additional information becomes available, a follow up report will be submitted.No other information is available that could confirm/deny the alleged event.At this time this report is considered final.(b)(4).
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Event or Problem Description
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Information from literature article review: prospective phase ii trial of drug-eluting bead chemoembolization for liver transplant candidates with hepatocellular carcinoma and marginal hepatic reserve - nicholas fidelman et al.Deb-tace was performed with up to two 2-ml vials of spherical polyvinyl alcohol microspheres (lc bead® 100 - 300 microns); impregnated per standard manufacturer supplied protocol with a total of 100 mg of reconstituted doxorubicin hydrochloride powder (25 mg per millilitre of beads).A total of 17 patients (median age 66 years, range 58-73 years; 13 men) were treated with at least 1 deb-tace procedure during the first stage of the study.Hepatitis c virus infection was the most common cause for cirrhosis (8 patients, 47%).The majority of the patients qualified for inclusion based on presence of symptomatic ascites (14 patients, 82%), serum bilirubin between 3 and 6 mg/dl (5 patients, 29%), and/or coagulopathy (4 patients, 24%).Three patients qualified for inclusion based on presence of main portal vein thrombosis, patent trans-jugular intrahepatic portosystemic shunt (tips), or a patent surgical shunt.Median ctp score was 10 (range 6-12), and median meld score was 12 (range 7-26).Most study participants (12 patients, 71%) had hcc within milan criteria at the time of inclusion.Median lesion size was 3 cm (range 1.1-6.5 cm).Solitary lesions were present for 14 patients, while 2 patients had 2 lesions each, and 1 patient had 4 lesions.Prior to inclusion in the study, seven patients (41%) had received between one and seven (median 3) liver-directed therapy procedures, which included conventional or debtace (5 and 7 patients, respectively) or radiofrequency ablation (3 patients).A total of 37 deb-tace procedures were performed for the 17 enrolled patients.Nine patients (53%) were treated once, three patients twice, one patient three times, three patients four times, and one patient seven times.Median time interval between deb-tace was 2 months (range 1- 7 months).Median doxorubicin dose administered during each procedure was 49 mg (range 4.9-98 mg).No major protocol deviations were encountered.All patients experienced at least one ae as a result of the deb-tace procedures (see table): aes were self-limited grade 1 or 2 fatigue, anorexia, nausea, abdominal pain, and insomnia, all of which resolved within 1 month of deb-tace.New grade 3 or 4 ae attributed to deb-tace occurred in 13 patients (76%).Seven patients (41%) developed symptoms of fluid retention.Three patients (18%) had worsening ascites, two of whom started requiring periodic large volume paracenteses, while one was successfully treated with diuretics.New or worsening lower extremity edema developed in six patients (35%) within one month of deb tace.Symptoms were grade 1 or 2 in severity for four patients and resolved after supportive treatment and/or diuretics within one month of onset.Two patients elevation n=3), thrombocytopenia (n=3), anemia (n=2), and creatinine elevation (n=1).All grade 3 ae returned to baseline majority within 30 days of deb-tace), except for 1 patient with hyperbilirubinemia that was attributed to an unplanned total hip arthroplasty performed 10 days following deb-tace and 1 patient with thrombocytopenia as well as grade 4 hyponatremia.Hepatic failure grade 3 (defined in nci ctcae v 4.03 as asterixis,mild encephalopathy, and limited ability to perform activities of daily living) was observed for 4 patients and was deemed unrelated to deb-tace for 2 patients (1 patient with previously prescribed diuretic medication non-compliance and 1 patient who underwent an unplanned total hip arthroplasty 10 days following deb-tace).Grade 3 hepatic failure resolved with supportive measures for three of the patients less than 1 month after the preceding deb-tace procedure.The fourth patient was found to have metastatic hcc to the brain and died 3 months after deb-tace.One patient died from liver failure 1.8 months following the first deb-tace, which may have been related to deb-tace.Echocardiograms demonstrated no significant change in myocardial function.Median left ventricular ejection fraction was 70% at baseline (range 66-81%) and 68% at 1 month following last pre-planned deb-tace (range 60-74%).Procedure-related mortality was 1 out of 17 (6%).
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