| Model Number 100-300, 300-500 UM |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Biliary Cirrhosis (1736); Death (1802); Fatigue (1849); Fever (1858); Hair Loss (1877); Nausea (1970); Vomiting (2144); Urticaria (2278); Ascites (2596); Weight Changes (2607); No Code Available (3191)
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Event Type
Death
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Manufacturer Narrative
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Dc bead (with doxorubicin hydrochloride) was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.
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Event Description
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Death of unknown cause [death]; progressive disease [disease progression]; progressive disease (intrahepatic and extrahepatic distant recurrence, local tumor progression and gross vascular invasion) [disease progression] prominent biliary injury (symptomatic in 4 patients) [biliary tract disorder]; ascites [ascites]; postembolization syndrome [post embolisation syndrome] cerebral infarction [cerebral infarction]; abdominal pain (grade 1 to grade 3) [abdominal pain]; nausea (grade 1 to grade 3) [nausea]; urticaria (grade 1 to grade 3) [urticaria]; persistent deterioration of liver function (two or more points in child-pugh score) [hepatic function abnormal] fatigue (grade 1) [fatigue]; vomiting (grade 1 to grade 2) [vomiting]; fever (grade 1 to grade 2) [pyrexia]; anorexia (grade 1 to grade 2) [decreased appetite]; alopecia (grade 1) [alopecia]; puncture site hematoma (grade 1) [vessel puncture site haematoma]; transient serum aspartate aminotransferase level worsened [aspartate aminotransferase increased]; transient serum alanine aminotransferase level worsened [alanine aminotransferase increased]; transient serum aspartate aminotransferase and aspartate aminotransferase levels worsened [condition aggravated].Case description: initial information received on 08-dec-2016: this spontaneous medical device report was received from a literature article by lee m.Et al entitled "korean multicenter registry of transcatheter arterial chemoembolization with drug-eluting embolic agents for nodular hepatocellular carcinomas: six-month outcome analysis" published in the journal of vascular and interventional radiology, concerning a group of 152 asian patients (17.8% were women), with mean age of 61.4 years (range, 34-86 years).The patients' medical history included hepatocellular carcinoma (hcc) (clinical or histologic diagnosis of hcc by aasld criteria) (single nodular or multinodular hcc with > or = to measureable hypervascular tumor on dynamic ct or mr imaging); not suitable for curative treatments or rejects such treatments, ecog performance status of 0/1, (114 (75.0%) had a performance status of 0), child-pugh class/score a5, a6, or b7, (103 (67.8%) had a child-pugh class/score of a5), and 77 (50.7%) had barcelona clinic liver cancer (bclc) stage a disease.The following laboratory inclusion criteria (< or = to 2 week) were assessed: white blood cell count > 3,000/mm^3, platelet count > 5 x 10^4/mm^3, serum bilirubin level < 3.0 mg/dl, serum ast and alt level < 5x upper limit of normal, serum creatinine level < 1.5 mg/dl, and hemoglobin level > 8.0 g/dl.The patients' concomitant medications were not provided.On an unspecified date, the patients received dc bead 100-300 micrometers or 30-500 micrometers loaded with 70-75 mg of adriamycin (doxorubicin) solution for at least 2 hours (loading dose, 35-37.5 mg/ml of embolic agent), and the preparation was suspended in 20-50 ml of a mixture of normal saline solution and non-ionic iodized contrast agent.The mixture was typically prepared at a 1:1 ratio of normal saline solution and contrast agent and adjusted to minimize precipitation of the embolic agent.Procedures were performed under fluoroscopy and angiography guidance, and rotational c-arm computed tomography (ct) or ct angiography was used based on operator decision.The microcatheter was placed as distally as possible into the vessel supplying the tumor.Dc bead suspension was injected as slowly as possible to avoid reflux of the suspension and non-target embolization.Recommended time for infusion was more than 20 minutes per vial.Dc bead agents were used for extrahepatic arteries supplying the tumors.The recommended embolization endpoint was near-stasis.In patients with large tumor burden, when hepatic arterial flow did not reach near-stasis after injection of two vials of dc bead agents, a separate treatment session was recommended at a 2-4-week interval as a second session in the first cycle.Tumor response assessment was performed with dynamic contrast-enhanced ct or magnetic resonance (mr) imaging at 1, 3, and 6 months after the procedure and at 3-month intervals thereafter.Repeated cycles of dc bead chemoembolization were recommended at 2-3-month intervals in case of viable tumor on imaging follow-up.Post-embolization syndrome (pes) was reported in 73.0% of patients (111 of 152) after the first treatment cycle, 57.4% (35 of 61) after the second cycle, and 50.0% (six of 12) after the third cycle.The overall incidence of pes was 67.6% (152 of 225).Prolonged hospitalization or readmission as a result of pes was reported in five patients.The most common adverse event were abdominal pain (grade 1 to grade 3), followed by nausea (grade 1 to grade 3), vomiting (grade 1 to grade 2), and fever (grade 1 to grade 2).The severity of the symptoms was almost always mild and classified as grade 1 or 2.There were only two patients with grade 3 symptoms.Mean hospital stay after the first cycle was 2.47 days - 1.50 (range, 1-9 d).Anorexia (grade 1 to grade 2), fatigue (grade 1), alopecia (grade 1), urticaria (grade 1 to grade 3) and puncture site hematoma (grade 1) were reported.Transient serum aspartate aminotransferase and alanine aminotransferase levels worsening were observed in the immediate post-treatment period after the first dc bead chemoembolization.However, on 1-month and 6-month follow-up, the findings became similar to those of baseline assessment.On an unspecified date, prominent biliary injury was demonstrated on imaging in 30 of 152 patients (19.7%).Among them, four patients (3.3%) were symptomatic and required readmission to the hospital as a result of the biliary injury.(this was reported in 4 patients).Readmission to the hospital to control ascites was reported in one patient.Another patient was admitted as a result of unrelated cerebral infarction.At one-month follow-up, three patients showed progressive disease caused by intrahepatic distant recurrence (idr).Only one patient showed persistent deterioration of liver function (two or more points in child-pugh score).At six-month follow-up, two patients showed deterioration of liver function beyond child-pugh b7 status.Both patients had progressive disease.Two patients died during the 6-month follow-up: one patient with partial response (pr) status died at 5 months after initial dc bead chemoembolization of an unknown cause.Another patient died at 6 months as a result of progressive disease.At the time of protocol termination, 15 of the 46 patients showed progressive disease.The most common cause of progressive disease was local tumor progression (ltp) in 32 patients (60.4%), followed by intrahepatic distant recurrence (idr) in 12 (22.6%), idr and ltp in eight (15.1%), and ltp, gross vascular invasion, and extrahepatic distant metastasis in one (1.9%).Two patients died after protocol termination: after living donor liver transplantation in one and after conversion to conventional chemoembolization as a result of progressive disease in the other.On an unspecified date, three patients had persistent deterioration of liver function after conversion to other treatments.Patients recovered from transient serum aspartate aminotransferase and alanine aminotransferase levels worsening on an unspecified date on 1-month follow-up and the outcome of the events progressive disease, prominent biliary injury , ascites, post-embolization syndrome , cerebral infarction, abdominal pain , nausea, urticaria, persistent deterioration of liver function, fatigue, vomiting , fever, anorexia, alopecia and puncture site hematoma was unknown.The authors assessed the events death of unknown cause, progressive disease, prominent biliary injury, ascites, postembolization syndrome, abdominal pain, nausea, urticaria and persistent deterioration of liver function to be serious (fatal, hospitalization or prolongation of hospitalization, medically significant) and the events fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma, transient serum aspartate aminotransferase and alanine aminotransferase levels worsened as non-serious.The authors assessed the events of prominent biliary injury, postembolization syndrome, abdominal pain, nausea, urticaria, persistent deterioration of liver function, fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma and transient serum aspartate aminotransferase and aspartate aminotransferase levels worsened as related to dc bead chemoembolization; and the events of progressive disease, progressive disease (intrahepatic and extrahepatic distant recurrence, local tumor progression and gross vascular invasion) and cerebral infarction as not related to dc bead chemoembolization.Additionally, the authors did not provide a causality assessment for 'death of unknown cause' and ascites.The authors reported that biliary injury is a well-known complication after chemoembolization and less selective delivery with an endpoint of complete stasis can cause prominent biliary injury after dc bead chemoembolization in a high percentage of patients.The company assessed the events death of unknown cause, progressive disease, prominent biliary injury, ascites, postembolization syndrome, abdominal pain, nausea, urticaria and persistent deterioration of liver function to be serious (fatal, hospitalization or prolongation of hospitalization, medically significant) and the events fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma, transient serum aspartate aminotransferase and alanine aminotransferase levels worsened as non-serious.Follow-up information will be requested.Case comment: post embolisation syndrome, cerebral infarction, abdominal pain, nausea, urticaria, hepatic function abnormal, vomiting, pyrexia, decreased appetite, alopecia, vessel puncture site haematoma, aspartate aminotransferase and alanine aminotransferase increased are considered listed and death, disease progression, biliary tract disorder, ascites and fatigue are considered unlisted according to dc bead current reference safety information.In line with the assessment made by the authors, and considering the plausible temporal sequence, the company considered postembolization syndrome, abdominal pain, nausea, persistent deterioration of liver function, fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma and transient serum aspartate aminotransferase and aspartate aminotransferase levels worsened to be related to the use of dc bead.Cerebral infarction was considered by the company as a recognised complication and therefore related to dc bead.The company considers that death, intrahepatic and extrahepatic distant recurrence, local tumor progression and gross vascular invasion, prominent biliary injury, ascites and urticaria were not related to the use of dc bead and rather related to disease progression.Nausea, urticaria and abdominal pain might be related to doxorubicin.
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Manufacturer Narrative
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Dc bead (with doxorubicin hydrochloride) was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.
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Event Description
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Death of unknown cause.Progressive disease.Progressive disease (intrahepatic and extrahepatic distant recurrence, local tumor progression and gross vascular invasion).Prominent biliary injury (symptomatic in 4 patients) [biliary tract disorder].Ascites.Postembolization syndrome.Cerebral infarction.Abdominal pain (grade 1 to grade 3).Nausea (grade 1 to grade 3).Urticaria (grade 1 to grade 3).Persistent deterioration of liver function (two or more points in child-pugh score) [hepatic function abnormal].Fatigue (grade 1).Vomiting (grade 1 to grade 2).Fever (grade 1 to grade 2) [pyrexia].Anorexia (grade 1 to grade 2) [decreased appetite].Alopecia (grade 1).Puncture site hematoma (grade 1).Transient serum aspartate aminotransferase level worsened.Transient serum alanine aminotransferase level worsened.Transient serum aspartate aminotransferase and aspartate aminotransferase levels worsened [condition aggravated].Case description: initial information received on 08-dec-2016: this spontaneous medical device report was received from a literature article by lee m.Et al entitled "korean multicenter registry of transcatheter arterial chemoembolization with drug-eluting embolic agents for nodular hepatocellular carcinomas: six-month outcome analysis" published in the journal of vascular and interventional radiology, concerning a group of 152 asian patients (17.8% were women), with mean age of 61.4 years (range, 34-86 years).The patients' medical history included hepatocellular carcinoma (hcc) (clinical or histologic diagnosis of hcc by aasld criteria) (single nodular or multinodular hcc with > or = to measureable hypervascular tumor on dynamic ct or mr imaging); not suitable for curative treatments or rejects such treatments, ecog performance status of 0/1, (114 (75.0%) had a performance status of 0), child-pugh class/score a5, a6, or b7, (103 (67.8%) had a child-pugh class/score of a5), and 77 (50.7%) had barcelona clinic liver cancer (bclc) stage a disease.The following laboratory inclusion criteria (< or = to 2 week) were assessed: white blood cell count > 3,000/mm^3, platelet count > 5 x 10^4/mm^3, serum bilirubin level < 3.0 mg/dl, serum ast and alt level < 5x upper limit of normal, serum creatinine level < 1.5 mg/dl, and hemoglobin level > 8.0 g/dl.The patients' concomitant medications were not provided.On an unspecified date, the patients received dc bead 100-300 micrometers or 30-500 micrometers loaded with 70-75 mg of adriamycin (doxorubicin) solution for at least 2 hours (loading dose, 35-37.5 mg/ml of embolic agent), and the preparation was suspended in 20-50 ml of a mixture of normal saline solution and non-ionic iodized contrast agent.The mixture was typically prepared at a 1:1 ratio of normal saline solution and contrast agent and adjusted to minimize precipitation of the embolic agent.Procedures were performed under fluoroscopy and angiography guidance, and rotational c-arm computed tomography (ct) or ct angiography was used based on operator decision.The microcatheter was placed as distally as possible into the vessel supplying the tumor.Dc bead suspension was injected as slowly as possible to avoid reflux of the suspension and non-target embolization.Recommended time for infusion was more than 20 minutes per vial.Dc bead agents were used for extrahepatic arteries supplying the tumors.The recommended embolization endpoint was near-stasis.In patients with large tumor burden, when hepatic arterial flow did not reach near-stasis after injection of two vials of dc bead agents, a separate treatment session was recommended at a 2-4-week interval as a second session in the first cycle.Tumor response assessment was performed with dynamic contrast-enhanced ct or magnetic resonance (mr) imaging at 1, 3, and 6 months after the procedure and at 3-month intervals thereafter.Repeated cycles of dc bead chemoembolization were recommended at 2-3-month intervals in case of viable tumor on imaging follow-up.Post-embolization syndrome (pes) was reported in 73.0% of patients (111 of 152) after the first treatment cycle, 57.4% (35 of 61) after the second cycle, and 50.0% (six of 12) after the third cycle.The overall incidence of pes was 67.6% (152 of 225).Prolonged hospitalization or readmission as a result of pes was reported in five patients.The most common adverse event were abdominal pain (grade 1 to grade 3), followed by nausea (grade 1 to grade 3), vomiting (grade 1 to grade 2), and fever (grade 1 to grade 2).The severity of the symptoms was almost always mild and classified as grade 1 or 2.There were only two patients with grade 3 symptoms.Mean hospital stay after the first cycle was 2.47 days - 1.50 (range, 1-9 d).Anorexia (grade 1 to grade 2), fatigue (grade 1), alopecia (grade 1), urticaria (grade 1 to grade 3) and puncture site hematoma (grade 1) were reported.Transient serum aspartate aminotransferase and alanine aminotransferase levels worsening were observed in the immediate post-treatment period after the first dc bead chemoembolization.However, on 1-month and 6-month follow-up, the findings became similar to those of baseline assessment.On an unspecified date, prominent biliary injury was demonstrated on imaging in 30 of 152 patients (19.7%).Among them, four patients (3.3%) were symptomatic and required readmission to the hospital as a result of the biliary injury.(this was reported in 4 patients).Readmission to the hospital to control ascites was reported in one patient.Another patient was admitted as a result of unrelated cerebral infarction.At one-month follow-up, three patients showed progressive disease caused by intrahepatic distant recurrence (idr).Only one patient showed persistent deterioration of liver function (two or more points in child-pugh score).At six-month follow-up, two patients showed deterioration of liver function beyond child-pugh b7 status.Both patients had progressive disease.Two patients died during the 6-month follow-up: one patient with partial response (pr) status died at 5 months after initial dc bead chemoembolization of an unknown cause.Another patient died at 6 months as a result of progressive disease.At the time of protocol termination, 15 of the 46 patients showed progressive disease.The most common cause of progressive disease was local tumor progression (ltp) in 32 patients (60.4%), followed by intrahepatic distant recurrence (idr) in 12 (22.6%), idr and ltp in eight (15.1%), and ltp, gross vascular invasion, and extrahepatic distant metastasis in one (1.9%).Two patients died after protocol termination: after living donor liver transplantation in one and after conversion to conventional chemoembolization as a result of progressive disease in the other.On an unspecified date, three patients had persistent deterioration of liver function after conversion to other treatments.Patients recovered from transient serum aspartate aminotransferase and alanine aminotransferase levels worsening on an unspecified date on 1-month follow-up and the outcome of the events progressive disease, prominent biliary injury , ascites, post-embolization syndrome , cerebral infarction, abdominal pain , nausea, urticaria, persistent deterioration of liver function, fatigue, vomiting , fever, anorexia, alopecia and puncture site hematoma was unknown.The authors assessed the events death of unknown cause, progressive disease, prominent biliary injury, ascites, postembolization syndrome, abdominal pain, nausea, urticaria and persistent deterioration of liver function to be serious (fatal, hospitalization or prolongation of hospitalization, medically significant) and the events fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma, transient serum aspartate aminotransferase and alanine aminotransferase levels worsened as non-serious.The authors assessed the events of prominent biliary injury, postembolization syndrome, abdominal pain, nausea, urticaria, persistent deterioration of liver function, fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma and transient serum aspartate aminotransferase and aspartate aminotransferase levels worsened as related to dc bead chemoembolization; and the events of progressive disease, progressive disease (intrahepatic and extrahepatic distant recurrence, local tumor progression and gross vascular invasion) and cerebral infarction as not related to dc bead chemoembolization.Additionally, the authors did not provide a causality assessment for 'death of unknown cause' and ascites.The authors reported that biliary injury is a well-known complication after chemoembolization and less selective delivery with an endpoint of complete stasis can cause prominent biliary injury after dc bead chemoembolization in a high percentage of patients.The company assessed the events death of unknown cause, progressive disease, prominent biliary injury, ascites, postembolization syndrome, abdominal pain, nausea, urticaria and persistent deterioration of liver function to be serious (fatal, hospitalization or prolongation of hospitalization, medically significant) and the events fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma, transient serum aspartate aminotransferase and alanine aminotransferase levels worsened as non-serious.Follow-up information will be requested.Final assessment on 30-dec-2016: follow-up information has been sought.On 23-dec-2016, the reporter confirmed that no additional information will be provided.This case is considered to be lost to follow-up.No device failure has been identified as a result of these adverse events.It has been assessed that no corrective action is necessary at this time.This report is final.Case comment: post embolisation syndrome, cerebral infarction, abdominal pain, nausea, urticaria, hepatic function abnormal, vomiting, pyrexia, decreased appetite, alopecia, vessel puncture site haematoma, aspartate aminotransferase and alanine aminotransferase increased are considered listed and death, disease progression, biliary tract disorder, ascites and fatigue are considered unlisted according to dc bead current reference safety information.In line with the assessment made by the authors, and considering the plausible temporal sequence, the company considered postembolization syndrome, abdominal pain, nausea, persistent deterioration of liver function, fatigue, vomiting, fever, anorexia, alopecia, puncture site hematoma and transient serum aspartate aminotransferase and aspartate aminotransferase levels worsened to be related to the use of dc bead.Cerebral infarction was considered by the company as a recognised complication and therefore related to dc bead.The company considers that death, intrahepatic and extrahepatic distant recurrence, local tumor progression and gross vascular invasion, prominent biliary injury, ascites and urticaria were not related to the use of dc bead and rather related to disease progression.Nausea, urticaria and abdominal pain might be related to doxorubicin.
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