| Model Number 100-300 MICROMETERS |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Death (1802); Hiccups (1899); Liver Damage/Dysfunction (1954); Pleural Effusion (2010); Rash (2033); Vomiting (2144); Respiratory Failure (2484)
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Event Type
Death
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Event Description
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One (1) patient died 3.7 months after dee/ 4 patients died during the follow-up period.Transient hepatoxicity/ laboratory hepatotoxicity.Right pleural effusion (grade 3).Respiratory decompensation [acute respiratory failure].50% of patients ultimately had tumor progression.Painful papular rash in a vascular distribution.Abdominal pain.Vomiting.Intractable hiccups.Two vials of 100-300 um lc bead microspheres were admixed with 50-75 mg of doxorubicin hydrochloride per vial overnight [off label use of device].Case description: initial information received on 07-dec-2016: this spontaneous medical device report was received from a literature article by lokken r.P., et al.Entitled "safety and efficacy of doxorubicin drug-eluting embolic chemoembolization of hepatocellular carcinoma supplied by extrahepatic collateral arteries" published in the journal of vascular and interventional radiology, concerning a subgroup of 16 patients (13 men and 3 women), with median age 66 years (range, 54-83 years), of which 12 experienced adverse events.The patients' medical history included hepatocellular carcinoma (hcc); 8 patients had a child-pugh class a, 6 patients had a child-pugh class b and 2 patients had a child-pugh class c.Prior locoregional therapy was performed upon 14 tumours (82.4%); 14 tumours (82.4%) had been treated with a median of 1.5 transarterial chemoembolization procedures (range, 1-6 procedures), 2 tumours (11.8%) had been previously treated with yttrium-90 radioembolization, and 3 tumours (17.6%) had been treated with radiofrequency ablation.Furthermore, before drug-eluting embolic (dee) transarterial chemoembolization, all patients underwent ct or mr imaging using a multiphase liver imaging protocol.The median lesion size was 3.1 cm (range, 1.0-10.3 cm) at the time of extrahepatic arterial supply detection.The patients' concomitant medication included gelfoam (pfizer inc.), which was administered to parenchymal branches before dee chemoembolization of the parasitized branch, in 4 of 19 (21.1%) right inferior phrenic artery (ripa) and 1 of 2 (50%) cystic artery procedures for an unknown indication.Furthermore, adjunctive maneuvers were performed in 6 of 24 (25.0%) procedures to protect extrahepatic parenchyma because superselective catheterization of parasitized branches could not be performed.In 2 of 4 (50%) adrenal artery procedures, the left inferior phrenic artery (lipa) branch was coiled before dee chemoembolization of the left superior adrenal artery.On an unspecified date, between jun-2011 and jul-2014, the patients received 2 vials of lc bead (bead size: 100-300 micrometers, lot number and expiration date not reported) admixed with 50-75 mg of doxorubicin hydrochloride per vial overnight.After discarding the supernatant, the microspheres were suspended in 10 ml of iodinated contrast agent (omnipaque 350; ge healthcare, (b)(4)) per vial before intraarterial administration.Dee transarterial chemoembolization was performed after digital subtraction angiography (dsa) of celiac and superior mesenteric arteries with a 5-f catheter and selective angiography of higher order branches with a coaxially placed 2.4- to 2.8-f microcatheter (renegade stc-18 and renegade hiflo; boston scientific, (b)(4)).Extrahepatic arterial supply was determined by computed tomography (ct) and magnetic resonance (mr) imaging performed earlier and intraprocedural dsa.Extrahepatic arteries were evaluated with dsa and, at operator discretion, cone-beam ct to confirm tumoral perfusion before dee transarterial chemoembolization.Dee transarterial chemoembolization was administered to angiographic stasis or a maximum of 2 vials of lc bead microspheres.Dee transarterial chemoembolization was performed via hepatic artery branches in the same procedure at operator discretion.Dee chemoembolization was concurrently performed via hepatic arteries in 11 (45.3%) procedures before (n = 3) or after (n = 8) dee chemoembolization to extrahepatic arteries.Concurrent hepatic arterial dee chemoembolization was administered in 9 of 19 (47.4%) ripas and 2 of 4 (50%) adrenal artery procedures.The median administered doxorubicin dose was 75 mg (range, 15-150 mg).Following the protocol, a ct or mr imaging was performed 1 month after dee transarterial chemoembolization and every 3 months thereafter.Dee chemoembolization was repeated at 1- month intervals if there was evidence of viable tumour.In 15 patients (93.8%) who underwent 21 of 24 (87.5%) dee transarterial chemoembolizations, ct or mr imaging was performed after the procedure.The initial follow-up ct or mr imaging scan was obtained at 1-2 months after 17 procedures (70.8%) and at 3-4 months after 4 (16.6%) procedures.All patients underwent follow-up evaluation 1 day after the procedure and additional clinical visits within 5 months.Patients were followed a median 12.0 months (range, 0.2-32.8 months).At the time of dee transarterial chemoembolization, 6 patients were listed for liver transplant.Of these, 4 proceeded to transplant, with mean time to transplant of 13.4 months +/- 1.6 after dee chemoembolization; among patients who were listed for transplant but did not receive a transplant, 1 patient was still on the waiting list at 16.6 months and, on an unspecified date, 3.7 months after dee chemoembolization, 1 patient died.It was not reported if an autopsy was performed.The cause of death was not reported.At the time of dee transarterial chemoembolization, 10 patients were not transplant candidates because they exceeded milan criteria in 9 cases and because of comorbidities in 1 case.Of these patients, on an unspecified date, during the follow-up period (40%), 4 patients died, with estimated mean survival time of 22.0 months +/- 2.9 after dee transarterial chemoembolization.It was not reported if an autopsy was performed.The cause of death was not reported.Complications occurred after 8 of 24 dee transarterial chemoembolization procedures (33.3%) in 8 of 16 patients (50.0%).On an unknown date, after ripa dee transarterial chemoembolization, 2 patients (1 grade 3, 1 grade 4) experienced transient laboratory hepatoxicity (characterized by aspartate aminotransferase elevation), that resolved 4 days and 22 days after dee embolization.In both patients, 1 or 2 hepatic segments were concurrently treated with dee transarterial chemoembolization via hepatic arterial branches; in 1 patient, a gelfoam pledget had been administered to distal ripa branches before dee chemoembolization.The event resolved on an unspecified date, between 4-80 days and was otherwise clinically silent.On an unknown date, after ripa dee transarterial chemoembolization, 1 patient experienced right pleural effusion (grade 3), resulting in respiratory decompensation and hospital admission 20 days after the procedure.The effusion was managed with thoracentesis and did not resolve in the following 12.7 months preceding liver transplant.Additionally, this patient, on an unknown date, also developed a transient grade 3 total bilirubin elevation and may have been secondary to hepatic decompensation and hepatic hydrothorax.No hepatic arterial dee chemoembolization had been concurrently performed.A gelfoam pledget had been administered to distal ripa branches before dee transarterial chemoembolization of parasitized branches.The event resolved on an unspecified date, within 80 days of dee transarterial chemoembolization.On an unspecified date, 1 day after the ripa dee transarterial chemoembolization, 1 patient developed painful, papular rash (grade 1).The patient did not received concurrent dee transarterial chemoembolization to hepatic arteries, and no intercostal or cutaneous perfusion was discernible.The treatment and the outcome were not reported.On an unknown date, 2 patients who received cystic artery dee transarterial chemoembolization developed grade 3 total bilirubin elevations.Neither patient had received concurrent dee transarterial chemoembolization via hepatic arteries.In 1 patient, gelfoam had been administered to distal cystic artery branches to protect the gallbladder.In the other patient, dee transarterial chemoembolization was administered to a cystic artery branch supplying tumour without adjunctive measures.The event resolved within 6 days and 17 days after the procedure, respectively, without additional evidence of cholecystitis.On an unspecified date, 2 days after 1 of 4 adrenal artery dee transarterial chemoembolization procedures, 1 patient presented to the emergency department with abdominal pain, vomiting and intractable hiccups (grade 2).In this patient, dee chemoembolization was administered to a left superior adrenal branch arising from the lipa; before dee administration, embolization of the distal lipa was performed with coils to protect parenchymal branches.Two additional hepatic segments were concurrently treated via branches of the hepatic artery.On an unknown date, the events resolved with outpatient therapy.On an unknown date, progression was ultimately observed in 8 tumours, with a mean time to progression of 8.3 months +/- 1.1 after dee transarterial chemoembolization.The authors considered the events of transient hepatoxicity/laboratory hepatotoxicity, right pleural effusion and respiratory decompensation as major complications, and the events painful papular rash in a vascular distribution, abdominal pain, vomiting and intractable hiccups as minor complications.The authors did not provide the seriousness of the events of death and disease progression.Additionally, the authors did not provide a causality assessment of the events of death, painful papular rash in a vascular distribution, abdominal pain, vomiting and hiccups to the use of bead block.However, the authors considered the events transient hepatoxicity/laboratory hepatotoxicity and right pleural effusion as known risks of hepatic arterial conventional and dee transarterial chemoembolization.Pleural effusion is a recognized complication of inferior phrenic artery conventional transarterial chemoembolization.The authors also stated that although 50% of patients ultimately had tumour progression, extrahepatic arterial dee transarterial chemoembolization facilitated bridging to liver transplant in 4 of 6 patients (67%) listed for liver transplant.The company assessed the events death, transient hepatoxicity/laboratory hepatotoxicity, right pleural effusion and respiratory decompensation and disease progression as serious (fatal, hospitalization, intervention required, medically significant) and the events painful papular rash in a vascular distribution, abdominal pain, vomiting and intractable hiccups as non-serious.This case is linked with case (b)(4), originating from the same literature article.Follow-up information will be requested.Case comments: the events hepatotoxicity, pleural effusion, acute respiratory failure, disease progression, rash papular, abdominal pain, vomiting, hiccups and off label use of device are considered unlisted according to the lc bead, current reference safety information, whereas the event death is listed.In line with the assessment made by the reporter, and considering the plausible temporal sequence, the company considered hepatotoxicity and pleural effusion and acute respiratory failure related to the use of lc bead.Also, in line with the assessment made by the authors, the company considered disease progression not related to the use of lc bead, but with the natural progression of the disease.Additionally, in the absence of an assessment made by the reporter, the company considered death, rash papular, abdominal pain, vomiting and hiccups related to the use of lc bead.Off label use of device is not an adverse event per se but a special scenario and therefore not assessable.This single case report does not modify the risk benefit balance of lc bead.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
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Event Description
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One (1) patient died 3.7 months after dee/ 4 patients died during the follow-up period.Transient hepatoxicity/ laboratory hepatotoxicity.Right pleural effusion (grade 3).Respiratory decompensation [acute respiratory failure].50% of patients ultimately had tumor progression.Painful papular rash in a vascular distribution.Abdominal pain.Vomiting.Intractable hiccups.Two vials of 100-300 um lc bead microspheres were admixed with 50-75 mg of doxorubicin hydrochloride per vial overnight [off label use of device].Case description: initial information received on 07-dec-2016: this spontaneous medical device report was received from a literature article by lokken r.P., et al.Entitled "safety and efficacy of doxorubicin drug-eluting embolic chemoembolization of hepatocellular carcinoma supplied by extrahepatic collateral arteries" published in the journal of vascular and interventional radiology, concerning a subgroup of 16 patients (13 men and 3 women), with median age 66 years (range, 54-83 years), of which 12 experienced adverse events.The patients' medical history included hepatocellular carcinoma (hcc); 8 patients had a child-pugh class a, 6 patients had a child-pugh class b and 2 patients had a child-pugh class c.Prior locoregional therapy was performed upon 14 tumours (82.4%); 14 tumours (82.4%) had been treated with a median of 1.5 transarterial chemoembolization procedures (range, 1-6 procedures), 2 tumours (11.8%) had been previously treated with yttrium-90 radioembolization, and 3 tumours (17.6%) had been treated with radiofrequency ablation.Furthermore, before drug-eluting embolic (dee) transarterial chemoembolization, all patients underwent ct or mr imaging using a multiphase liver imaging protocol.The median lesion size was 3.1 cm (range, 1.0-10.3 cm) at the time of extrahepatic arterial supply detection.The patients' concomitant medication included gelfoam (pfizer inc.), which was administered to parenchymal branches before dee chemoembolization of the parasitized branch, in 4 of 19 (21.1%) right inferior phrenic artery (ripa) and 1 of 2 (50%) cystic artery procedures for an unknown indication.Furthermore, adjunctive maneuvers were performed in 6 of 24 (25.0%) procedures to protect extrahepatic parenchyma because superselective catheterization of parasitized branches could not be performed.In 2 of 4 (50%) adrenal artery procedures, the left inferior phrenic artery (lipa) branch was coiled before dee chemoembolization of the left superior adrenal artery.On an unspecified date, between jun-2011 and jul-2014, the patients received 2 vials of lc bead (bead size: 100-300 micrometers, lot number and expiration date not reported) admixed with 50-75 mg of doxorubicin hydrochloride per vial overnight.After discarding the supernatant, the microspheres were suspended in 10 ml of iodinated contrast agent (omnipaque 350; ge healthcare, (b)(4)) per vial before intraarterial administration.Dee transarterial chemoembolization was performed after digital subtraction angiography (dsa) of celiac and superior mesenteric arteries with a 5-f catheter and selective angiography of higher order branches with a coaxially placed 2.4- to 2.8-f microcatheter (renegade stc-18 and renegade hiflo; boston scientific, (b)(4)).Extrahepatic arterial supply was determined by computed tomography (ct) and magnetic resonance (mr) imaging performed earlier and intraprocedural dsa.Extrahepatic arteries were evaluated with dsa and, at operator discretion, cone-beam ct to confirm tumoral perfusion before dee transarterial chemoembolization.Dee transarterial chemoembolization was administered to angiographic stasis or a maximum of 2 vials of lc bead microspheres.Dee transarterial chemoembolization was performed via hepatic artery branches in the same procedure at operator discretion.Dee chemoembolization was concurrently performed via hepatic arteries in 11 (45.3%) procedures before (n = 3) or after (n = 8) dee chemoembolization to extrahepatic arteries.Concurrent hepatic arterial dee chemoembolization was administered in 9 of 19 (47.4%) ripas and 2 of 4 (50%) adrenal artery procedures.The median administered doxorubicin dose was 75 mg (range, 15-150 mg).Following the protocol, a ct or mr imaging was performed 1 month after dee transarterial chemoembolization and every 3 months thereafter.Dee chemoembolization was repeated at 1- month intervals if there was evidence of viable tumour.In 15 patients (93.8%) who underwent 21 of 24 (87.5%) dee transarterial chemoembolizations, ct or mr imaging was performed after the procedure.The initial follow-up ct or mr imaging scan was obtained at 1-2 months after 17 procedures (70.8%) and at 3-4 months after 4 (16.6%) procedures.All patients underwent follow-up evaluation 1 day after the procedure and additional clinical visits within 5 months.Patients were followed a median 12.0 months (range, 0.2-32.8 months).At the time of dee transarterial chemoembolization, 6 patients were listed for liver transplant.Of these, 4 proceeded to transplant, with mean time to transplant of 13.4 months +/- 1.6 after dee chemoembolization; among patients who were listed for transplant but did not receive a transplant, 1 patient was still on the waiting list at 16.6 months and, on an unspecified date, 3.7 months after dee chemoembolization, 1 patient died.It was not reported if an autopsy was performed.The cause of death was not reported.At the time of dee transarterial chemoembolization, 10 patients were not transplant candidates because they exceeded milan criteria in 9 cases and because of comorbidities in 1 case.Of these patients, on an unspecified date, during the follow-up period (40%), 4 patients died, with estimated mean survival time of 22.0 months +/- 2.9 after dee transarterial chemoembolization.It was not reported if an autopsy was performed.The cause of death was not reported.Complications occurred after 8 of 24 dee transarterial chemoembolization procedures (33.3%) in 8 of 16 patients (50.0%).On an unknown date, after ripa dee transarterial chemoembolization, 2 patients (1 grade 3, 1 grade 4) experienced transient laboratory hepatoxicity (characterized by aspartate aminotransferase elevation), that resolved 4 days and 22 days after dee embolization.In both patients, 1 or 2 hepatic segments were concurrently treated with dee transarterial chemoembolization via hepatic arterial branches; in 1 patient, a gelfoam pledget had been administered to distal ripa branches before dee chemoembolization.The event resolved on an unspecified date, between 4-80 days and was otherwise clinically silent.On an unknown date, after ripa dee transarterial chemoembolization, 1 patient experienced right pleural effusion (grade 3), resulting in respiratory decompensation and hospital admission 20 days after the procedure.The effusion was managed with thoracentesis and did not resolve in the following 12.7 months preceding liver transplant.Additionally, this patient, on an unknown date, also developed a transient grade 3 total bilirubin elevation and may have been secondary to hepatic decompensation and hepatic hydrothorax.No hepatic arterial dee chemoembolization had been concurrently performed.A gelfoam pledget had been administered to distal ripa branches before dee transarterial chemoembolization of parasitized branches.The event resolved on an unspecified date, within 80 days of dee transarterial chemoembolization.On an unspecified date, 1 day after the ripa dee transarterial chemoembolization, 1 patient developed painful, papular rash (grade 1).The patient did not received concurrent dee transarterial chemoembolization to hepatic arteries, and no intercostal or cutaneous perfusion was discernible.The treatment and the outcome were not reported.On an unknown date, 2 patients who received cystic artery dee transarterial chemoembolization developed grade 3 total bilirubin elevations.Neither patient had received concurrent dee transarterial chemoembolization via hepatic arteries.In 1 patient, gelfoam had been administered to distal cystic artery branches to protect the gallbladder.In the other patient, dee transarterial chemoembolization was administered to a cystic artery branch supplying tumour without adjunctive measures.The event resolved within 6 days and 17 days after the procedure, respectively, without additional evidence of cholecystitis.On an unspecified date, 2 days after 1 of 4 adrenal artery dee transarterial chemoembolization procedures, 1 patient presented to the emergency department with abdominal pain, vomiting and intractable hiccups (grade 2).In this patient, dee chemoembolization was administered to a left superior adrenal branch arising from the lipa; before dee administration, embolization of the distal lipa was performed with coils to protect parenchymal branches.Two additional hepatic segments were concurrently treated via branches of the hepatic artery.On an unknown date, the events resolved with outpatient therapy.On an unknown date, progression was ultimately observed in 8 tumours, with a mean time to progression of 8.3 months +/- 1.1 after dee transarterial chemoembolization.The authors considered the events of transient hepatoxicity/laboratory hepatotoxicity, right pleural effusion and respiratory decompensation as major complications, and the events painful papular rash in a vascular distribution, abdominal pain, vomiting and intractable hiccups as minor complications.The authors did not provide the seriousness of the events of death and disease progression.Additionally, the authors did not provide a causality assessment of the events of death, painful papular rash in a vascular distribution, abdominal pain, vomiting and hiccups to the use of bead block.However, the authors considered the events transient hepatoxicity/laboratory hepatotoxicity and right pleural effusion as known risks of hepatic arterial conventional and dee transarterial chemoembolization.Pleural effusion is a recognized complication of inferior phrenic artery conventional transarterial chemoembolization.The authors also stated that although 50% of patients ultimately had tumour progression, extrahepatic arterial dee transarterial chemoembolization facilitated bridging to liver transplant in 4 of 6 patients (67%) listed for liver transplant.The company assessed the events death, transient hepatoxicity/laboratory hepatotoxicity, right pleural effusion and respiratory decompensation and disease progression as serious (fatal, hospitalization, intervention required, medically significant) and the events painful papular rash in a vascular distribution, abdominal pain, vomiting and intractable hiccups as non-serious.This case is linked with (b)(4), originating from the same literature article.Follow-up information will be requested.Update information on 19-dec-2016 and additional information on 06-jan-2017: the case comments were updated in accordance with the medical assessment provided.Follow up information has been sought to further investigate the events.As of 06-jan-2017 no additional information has been received.Case comments: the events hepatotoxicity, pleural effusion, acute respiratory failure, disease progression, rash papular, abdominal pain, vomiting, hiccups and off label use of device are considered unlisted according to the lc bead, current reference safety information, whereas the event death is listed.In line with the assessment made by the reporter, and considering the plausible temporal sequence, the company considered hepatotoxicity, pleural effusion and acute respiratory failure possibly related to the use of lc bead.Also, in line with the assessment made by the authors, the company considered disease progression not related to the use of lc bead, but with the natural progression of the disease.Additionally, in the absence of an assessment made by the reporter, the company considered rash papular, abdominal pain, vomiting and hiccups possibly to the use of lc bead.Although it is reasonable to assume that death is more likely to be associated with disease progression and condition of patient rather than treatment with lc bead, there is insufficient information at the present to assess that lc bead was not a contributor to cause of death, and as such the company considered death as possibly related.Off label use of device is not an adverse event per se but a special scenario and therefore not assessable.This single case report does not modify the risk benefit balance of lc bead.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
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Event Description
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One (1) patient died 3.7 months after dee/ 4 patients died during the follow-up period.Transient hepatoxicity/ laboratory hepatotoxicity.Right pleural effusion (grade 3).Respiratory decompensation [acute respiratory failure].50% of patients ultimately had tumor progression [disease progression].Painful papular rash in a vascular distribution.Abdominal pain.Vomiting.Intractable hiccups.Two vials of 100-300 um lc bead microspheres were admixed with 50-75 mg of doxorubicin hydrochloride per vial overnight [off label use of device].Case description: initial information received on 07-dec-2016: this spontaneous medical device report was received from a literature article by lokken r.P., et al.Entitled "safety and efficacy of doxorubicin drug-eluting embolic chemoembolization of hepatocellular carcinoma supplied by extrahepatic collateral arteries" published in the journal of vascular and interventional radiology, concerning a subgroup of 16 patients (13 men and 3 women), with median age 66 years (range, 54-83 years), of which 12 experienced adverse events.The patients' medical history included hepatocellular carcinoma (hcc); 8 patients had a child-pugh class a, 6 patients had a child-pugh class b and 2 patients had a child-pugh class c.Prior locoregional therapy was performed upon 14 tumours (82.4%); 14 tumours (82.4%) had been treated with a median of 1.5 transarterial chemoembolization procedures (range, 1-6 procedures), 2 tumours (11.8%) had been previously treated with yttrium-90 radioembolization, and 3 tumours (17.6%) had been treated with radiofrequency ablation.Furthermore, before drug-eluting embolic (dee) transarterial chemoembolization, all patients underwent ct or mr imaging using a multiphase liver imaging protocol.The median lesion size was 3.1 cm (range, 1.0-10.3 cm) at the time of extrahepatic arterial supply detection.The patients' concomitant medication included gelfoam (pfizer inc.), which was administered to parenchymal branches before dee chemoembolization of the parasitized branch, in 4 of 19 (21.1%) right inferior phrenic artery (ripa) and 1 of 2 (50%) cystic artery procedures for an unknown indication.Furthermore, adjunctive maneuvers were performed in 6 of 24 (25.0%) procedures to protect extrahepatic parenchyma because superselective catheterization of parasitized branches could not be performed.In 2 of 4 (50%) adrenal artery procedures, the left inferior phrenic artery (lipa) branch was coiled before dee chemoembolization of the left superior adrenal artery.On an unspecified date, between jun-2011 and jul-2014, the patients received 2 vials of lc bead (bead size: 100-300 micrometers, lot number and expiration date not reported) admixed with 50-75 mg of doxorubicin hydrochloride per vial overnight.After discarding the supernatant, the microspheres were suspended in 10 ml of iodinated contrast agent (omnipaque 350; ge healthcare, (b)(4)) per vial before intraarterial administration.Dee transarterial chemoembolization was performed after digital subtraction angiography (dsa) of celiac and superior mesenteric arteries with a 5-f catheter and selective angiography of higher order branches with a coaxially placed 2.4- to 2.8-f microcatheter (renegade stc-18 and renegade hiflo; boston scientific, (b)(4)).Extrahepatic arterial supply was determined by computed tomography (ct) and magnetic resonance (mr) imaging performed earlier and intraprocedural dsa.Extrahepatic arteries were evaluated with dsa and, at operator discretion, cone-beam ct to confirm tumoral perfusion before dee transarterial chemoembolization.Dee transarterial chemoembolization was administered to angiographic stasis or a maximum of 2 vials of lc bead microspheres.Dee transarterial chemoembolization was performed via hepatic artery branches in the same procedure at operator discretion.Dee chemoembolization was concurrently performed via hepatic arteries in 11 (45.3%) procedures before (n = 3) or after (n = 8) dee chemoembolization to extrahepatic arteries.Concurrent hepatic arterial dee chemoembolization was administered in 9 of 19 (47.4%) ripas and 2 of 4 (50%) adrenal artery procedures.The median administered doxorubicin dose was 75 mg (range, 15-150 mg).Following the protocol, a ct or mr imaging was performed 1 month after dee transarterial chemoembolization and every 3 months thereafter.Dee chemoembolization was repeated at 1- month intervals if there was evidence of viable tumour.In 15 patients (93.8%) who underwent 21 of 24 (87.5%) dee transarterial chemoembolizations, ct or mr imaging was performed after the procedure.The initial follow-up ct or mr imaging scan was obtained at 1-2 months after 17 procedures (70.8%) and at 3-4 months after 4 (16.6%) procedures.All patients underwent follow-up evaluation 1 day after the procedure and additional clinical visits within 5 months.Patients were followed a median 12.0 months (range, 0.2-32.8 months).At the time of dee transarterial chemoembolization, 6 patients were listed for liver transplant.Of these, 4 proceeded to transplant, with mean time to transplant of 13.4 months +/- 1.6 after dee chemoembolization; among patients who were listed for transplant but did not receive a transplant, 1 patient was still on the waiting list at 16.6 months and, on an unspecified date, 3.7 months after dee chemoembolization, 1 patient died.It was not reported if an autopsy was performed.The cause of death was not reported.At the time of dee transarterial chemoembolization, 10 patients were not transplant candidates because they exceeded milan criteria in 9 cases and because of comorbidities in 1 case.Of these patients, on an unspecified date, during the follow-up period (40%), 4 patients died, with estimated mean survival time of 22.0 months +/- 2.9 after dee transarterial chemoembolization.It was not reported if an autopsy was performed.The cause of death was not reported.Complications occurred after 8 of 24 dee transarterial chemoembolization procedures (33.3%) in 8 of 16 patients (50.0%).On an unknown date, after ripa dee transarterial chemoembolization, 2 patients (1 grade 3, 1 grade 4) experienced transient laboratory hepatoxicity (characterized by aspartate aminotransferase elevation), that resolved 4 days and 22 days after dee embolization.In both patients, 1 or 2 hepatic segments were concurrently treated with dee transarterial chemoembolization via hepatic arterial branches; in 1 patient, a gelfoam pledget had been administered to distal ripa branches before dee chemoembolization.The event resolved on an unspecified date, between 4-80 days and was otherwise clinically silent.On an unknown date, after ripa dee transarterial chemoembolization, 1 patient experienced right pleural effusion (grade 3), resulting in respiratory decompensation and hospital admission 20 days after the procedure.The effusion was managed with thoracentesis and did not resolve in the following 12.7 months preceding liver transplant.Additionally, this patient, on an unknown date, also developed a transient grade 3 total bilirubin elevation and may have been secondary to hepatic decompensation and hepatic hydrothorax.No hepatic arterial dee chemoembolization had been concurrently performed.A gelfoam pledget had been administered to distal ripa branches before dee transarterial chemoembolization of parasitized branches.The event resolved on an unspecified date, within 80 days of dee transarterial chemoembolization.On an unspecified date, 1 day after the ripa dee transarterial chemoembolization, 1 patient developed painful, papular rash (grade 1).The patient did not received concurrent dee transarterial chemoembolization to hepatic arteries, and no intercostal or cutaneous perfusion was discernible.The treatment and the outcome were not reported.On an unknown date, 2 patients who received cystic artery dee transarterial chemoembolization developed grade 3 total bilirubin elevations.Neither patient had received concurrent dee transarterial chemoembolization via hepatic arteries.In 1 patient, gelfoam had been administered to distal cystic artery branches to protect the gallbladder.In the other patient, dee transarterial chemoembolization was administered to a cystic artery branch supplying tumour without adjunctive measures.The event resolved within 6 days and 17 days after the procedure, respectively, without additional evidence of cholecystitis.On an unspecified date, 2 days after 1 of 4 adrenal artery dee transarterial chemoembolization procedures, 1 patient presented to the emergency department with abdominal pain, vomiting and intractable hiccups (grade 2).In this patient, dee chemoembolization was administered to a left superior adrenal branch arising from the lipa; before dee administration, embolization of the distal lipa was performed with coils to protect parenchymal branches.Two additional hepatic segments were concurrently treated via branches of the hepatic artery.On an unknown date, the events resolved with outpatient therapy.On an unknown date, progression was ultimately observed in 8 tumours, with a mean time to progression of 8.3 months +/- 1.1 after dee transarterial chemoembolization.The authors considered the events of transient hepatoxicity/laboratory hepatotoxicity, right pleural effusion and respiratory decompensation as major complications, and the events painful papular rash in a vascular distribution, abdominal pain, vomiting and intractable hiccups as minor complications.The authors did not provide the seriousness of the events of death and disease progression.Additionally, the authors did not provide a causality assessment of the events of death, painful papular rash in a vascular distribution, abdominal pain, vomiting and hiccups to the use of bead block.However, the authors considered the events transient hepatoxicity/laboratory hepatotoxicity and right pleural effusion as known risks of hepatic arterial conventional and dee transarterial chemoembolization.Pleural effusion is a recognized complication of inferior phrenic artery conventional transarterial chemoembolization.The authors also stated that although 50% of patients ultimately had tumour progression, extrahepatic arterial dee transarterial chemoembolization facilitated bridging to liver transplant in 4 of 6 patients (67%) listed for liver transplant.The company assessed the events death, transient hepatoxicity/laboratory hepatotoxicity, right pleural effusion and respiratory decompensation and disease progression as serious (fatal, hospitalization, intervention required, medically significant) and the events painful papular rash in a vascular distribution, abdominal pain, vomiting and intractable hiccups as non-serious.This case is linked with case (b)(4), originating from the same literature article.Follow-up information will be requested.Update information on 19-dec-2016 and additional information on 06-jan-2017: the case comments were updated in accordance with the medical assessment provided.Follow up information has been sought to further investigate the events.As of 06-jan-2017 no additional information has been received.Final assessment on 03-feb-2017: follow up information has been sought to further investigate the events but no new information has been received.After three follow up attempts, the case is considered lost to follow up.No device failure has been identified as a result of this adverse events.It has been assessed that no corrective action is necessary at this time and the report is considered final.Case comments: the events hepatotoxicity, pleural effusion, acute respiratory failure, disease progression, rash papular, abdominal pain, vomiting, hiccups and off label use of device are considered unlisted according to the lc bead, current reference safety information, whereas the event death is listed.In line with the assessment made by the reporter, and considering the plausible temporal sequence, the company considered hepatotoxicity, pleural effusion and acute respiratory failure possibly related to the use of lc bead.Also, in line with the assessment made by the authors, the company considered disease progression not related to the use of lc bead, but with the natural progression of the disease.Additionally, in the absence of an assessment made by the reporter, the company considered rash papular, abdominal pain, vomiting and hiccups possibly to the use of lc bead.Although it is reasonable to assume that death is more likely to be associated with disease progression and condition of patient rather than treatment with lc bead, there is insufficient information at the present to assess that lc bead was not a contributor to cause of death, and as such the company considered death as possibly related.Off label use of device is not an adverse event per se but a special scenario and therefore not assessable.This single case report does not modify the risk benefit balance of lc bead.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
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