| Model Number 70-150,100-300MICRON |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Death (1802); Encephalopathy (1833); Hemorrhage/Bleeding (1888); Pneumonia (2011); Sepsis (2067); Thrombosis (2100); Weakness (2145); Ulcer (2274); Ascites (2596)
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Event Type
Death
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Event Description
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Pneumonia [pneumonia].Sepsis [sepsis].Severe ascites [ascites].Abdominal pain/ right upper quadrant pain [abdominal pain].Encephalopathy [encephalopathy].Biliary ductal dilatation [biliary dilatation].Mrecist evaluation revealed progressive disease (pd) [disease progression].Mouth sores [stomatitis].Decreased oral intake [hypophagia].Weakness [asthenia].Cholecystitis [cholecystitis].Right portal vein thrombosis [portal vein thrombosis].Hematemesis [haematemesis].Tumoral bleeding [tumour haemorrhage].Gastrointestinal bleeding [gastrointestinal haemorrhage].Loaded with 50 mg of doxorubicin [off label use of device].Case description: initial information received on 18-may-2016: this literature case report was published in 2015 in the journal of vascular and interventional radiology by deipolyi ar et al.With the title "safety and efficacy of 70-150 microm and 100-300 microm drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma" and concerning 13 patients.The patients' medical history included hepatocellular carcinoma.No information concerning concomitant medication was provided.Between dec-2012 and dec-2013, the patients in group 2 received one vial of 70-150 microm lc bead m1 loaded with 50 mg of doxorubicin which was followed by one vial of 100-300 microm lc bead m1 loaded with 50 mg of doxorubicin as transarterial chemoembolization for unresectable hepatocellular carcinoma (hcc).On an unspecified date, a (b)(6) male patient with additional relevant medical history of hepatitis c virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 2.0 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 16 mm.The patient's child-pugh score was b.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, an (b)(6) male patient experienced encephalopathy and biliary ductal dilatation.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 31 mm.The patient's child-pugh score was a.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) female patient with additional relevant medical history of hepatitis c virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 1.4 mg/dl approximately 2 days prior to the procedure.Her index lesion was measured as 50 mm.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing into left lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) female patient with additional relevant medical history of hepatitis c virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.4 mg/dl approximately 2 days prior to the procedure.Her index lesion was measured as 14 mm.The patient's child-pugh score was a.This patient received her transarterial chemoembolization dosing selectively.The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with additional relevant medical history of hepatitis c virus experienced hematemesis.The patient's total bilirubin was 3.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 51 mm.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing selectively.The outcome of the event is unknown.On an unspecified date, an (b)(6) female patient experienced tumoral bleeding.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing selectively.The outcome of the event is unknown.On an unspecified date, within one month of treatment, a (b)(6) female patient with additional relevant medical history of primary biliary cirrhosis died at an outside hospital from pneumonia and sepsis after a re-admission for severe ascites, mouth sores, decreased oral intake, right upper quadrant pain and weakness.The patient's total bilirubin was 0.7 mg/dl approximately 2 days prior to the procedure.The patient's child-pugh score was a.The outcomes of the events of severe ascites, mouth sores, decreased oral intake, right upper quadrant pain and weakness at the time of death was unknown.The cause of death was noted as pneumonia and sepsis.On an unspecified date, an (b)(6) female patient with additional relevant medical history of nonalcoholic steatohepatitis (nash) experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.7 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 31 mm.The patient's child-pugh score was a.This patient received this dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 2.5 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 64 mm.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).This patient received his transarterial chemoembolization dosing bilobar.The outcomes of the events are unknown.On an unspecified date, the (b)(6) female patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 71 mm.The patient's child-pugh score was a.This patient received this dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with additional relevant medical history of (b)(6) experienced cholecystitis.Treatment included a cholecystectomy at an outside institution.The patient's total bilirubin was 1.9 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 28 mm.The patient's child-pugh score was a.This patient received the dosing into the right lobe.The outcome of the event is unknown.On an unspecified date, a (b)(6) female patient with additional relevant medical history of (b)(6) experienced acute cholecystitis.The patient's total bilirubin was 0.3 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 10 mm.Overnight, following treatment, the patient experienced severe right upper quadrant pain and was found to have acute cholecystitis on ct scan.This patient received this dosing into the right hepatic artery.Injection through the microcatheter positioned for treatment showed an opacification of the cystic artery.Treatment was managed conservatively with resolution of the cholecystitis.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).The outcomes of the events are unknown.On an unspecified date, after discharge, a (b)(6) male patient with additional relevant medical history of alcohol abuse (etoh) presented to the emergency department with gastrointestinal bleeding and was found to have new right portal vein thrombosis.At an unspecified date the patient experienced encephalopathy.The patient's total bilirubin was 1.0 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 33 mm.The patient's child-pugh score was a.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.The authors assessed the event of severe ascites/abdominal pain, gastrointestinal bleeding, portal vein thrombosis, encephalopathy, biliary ductal dilatation, hematemesis, tumoral bleeding as related to the use of lc bead m1.The author assessed the events of cholecystitis as related to the use of lc bead m1 due to the greater extent of coagulative necrosis induced by smaller drug eluding beads.The authors did not provide an assessment for the events of fatal pneumonia, fatal sepsis, disease progression, mouth sores, decreased oral intake and weakness.The company assessed the events of ascites, abdominal pain, biliary ductal dilatation, hematemesis, tumoral bleeding as serious (medically significant); cholecystitis as serious (intervention required, hospitalization, medically significant); gastrointestinal bleeding, portal vein thrombosis and encephalopathy as serious (hospitalization, medically significant).The company assessed the events of pneumonia, sepsis, stomatitis, hypophagia and asthenia as serious (fatal, hospitalization, medically significant) and the issue of off-label use as non-assessable.The case is linked to (b)(4) from the same literature article.Case comment: ascites, abdominal pain, encephalopathy, biliary ductal dilatation, cholecystitis, disease progression, stomatitis, hypophagia, asthenia and off label use of a device are considered unlisted as per lc bead m1 instructions for use.Sepsis, tumoral bleeding, hematemesis, gastrointestinal bleeding are considered listed as per lc bead m1 instructions for use.In agreement with the authors, the company considered the event of ascites, abdominal pain, hematemesis, encephalopathy, biliary ductal dilatation, cholecystitis, tumoral bleeding, portal vein thrombosis, gastrointestinal bleeding and disease progression as related to the device since this possibility cannot be excluded.Of note, the patients' abdominal pain was more likely related to the severe ascites.In absence of the authors' assessment, the company considers the events of sepsis, pneumonia, and stomatitis as related to the device since this possibility cannot be excluded.In absence of the authors' assessment, the company considers the events of hypophagia and asthenia as not related to the use of the device but hypophagia as due to stomatitis, and asthenia due to pneumonia and sepsis.Off-label use of device was considered non-assessable as an event.This single case report does not modify the risk benefit balance of lc bead m1.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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Pneumonia [pneumonia].Sepsis [sepsis].Severe ascites [ascites].Abdominal pain/ right upper quadrant pain [abdominal pain].Encephalopathy [encephalopathy].Biliary ductal dilatation [biliary dilatation].(b)(4) evaluation revealed progressive disease (pd) [disease progression].Mouth sores [stomatitis].Decreased oral intake [hypophagia].Weakness [asthenia].Cholecystitis [cholecystitis].Right portal vein thrombosis [portal vein thrombosis].Hematemesis [haematemesis].Tumoral bleeding [tumour haemorrhage].Gastrointestinal bleeding [gastrointestinal haemorrhage].Loaded with 50 mg of doxorubicin [off label use of device].Case description: initial information received on 18-may-2016: this literature case report was published in 2015 in the journal of vascular and interventional radiology by deipolyi ar et al.With the title "safety and efficacy of 70-150 microm and 100-300 microm drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma" and concerning 13 patients.The patients' medical history included hepatocellular carcinoma.No information concerning concomitant medication was provided.Between dec-2012 and dec-2013, the patients in group 2 received one vial of 70-150 microm lc bead m1 loaded with 50 mg of doxorubicin which was followed by one vial of 100-300 microm lc bead m1 loaded with 50 mg of doxorubicin as transarterial chemoembolization for unresectable hepatocellular carcinoma (hcc).On an unspecified date, a (b)(6) year old male patient with additional relevant medical history of (b)(6) virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 2.0 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 16 mm.The patient's child-pugh score was b.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, an (b)(6) year old male patient experienced encephalopathy and biliary ductal dilatation.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 31 mm.The patient's child-pugh score was a.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) year old female patient with additional relevant medical history of (b)(6) virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 1.4 mg/dl approximately 2 days prior to the procedure.Her index lesion was measured as 50 mm.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing into left lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) year old female patient with additional relevant medical history of (b)(6) virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.4 mg/dl approximately 2 days prior to the procedure.Her index lesion was measured as 14 mm.The patient's child-pugh score was a.This patient received her transarterial chemoembolization dosing selectively.The outcomes of the events are unknown.On an unspecified date, a 55 year old male patient with additional relevant medical history of hepatitis c virus experienced hematemesis.The patient's total bilirubin was 3.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 51 mm.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing selectively.The outcome of the event is unknown.On an unspecified date, an (b)(6) year old female patient experienced tumoral bleeding.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing selectively.The outcome of the event is unknown.On an unspecified date, within one month of treatment, a (b)(6) year old female patient with additional relevant medical history of primary biliary cirrhosis died at an outside hospital from pneumonia and sepsis after a re-admission for severe ascites, mouth sores, decreased oral intake, right upper quadrant pain and weakness.The patient's total bilirubin was 0.7 mg/dl approximately 2 days prior to the procedure.The patient's child-pugh score was a.The outcomes of the events of severe ascites, mouth sores, decreased oral intake, right upper quadrant pain and weakness at the time of death was unknown.The cause of death was noted as pneumonia and sepsis.On an unspecified date, an (b)(6) year old female patient with additional relevant medical history of nonalcoholic (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.7 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 31 mm.The patient's child-pugh score was a.This patient received this dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) year old male patient with additional relevant medical history of (b)(6) virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 2.5 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 64 mm.Following treatment with lc bead m1, the (b)(4) evaluation revealed progressive disease (pd).This patient received his transarterial chemoembolization dosing bilobar.The outcomes of the events are unknown.On an unspecified date, the (b)(6) year old female patient with additional relevant medical history of (b)(6) virus experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 71 mm.The patient's child-pugh score was a.This patient received this dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) year old male patient with additional relevant medical history of (b)(6) virus experienced cholecystitis.Treatment included a cholecystectomy at an outside institution.The patient's total bilirubin was 1.9 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 28 mm.The patient's child-pugh score was a.This patient received the dosing into the right lobe.The outcome of the event is unknown.On an unspecified date, a (b)(6) year old female patient with additional relevant medical history of (b)(6) virus experienced acute cholecystitis.The patient's total bilirubin was 0.3 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 10 mm.Overnight, following treatment, the patient experienced severe right upper quadrant pain and was found to have acute cholecystitis on ct scan.This patient received this dosing into the right hepatic artery.Injection through the microcatheter positioned for treatment showed an opacification of the cystic artery.Treatment was managed conservatively with resolution of the cholecystitis.Following treatment with lc bead m1, the (b)(4) evaluation revealed progressive disease (pd).The outcomes of the events are unknown.On an unspecified date, after discharge, a (b)(6) year old male patient with additional relevant medical history of alcohol abuse (etoh) presented to the emergency department with gastrointestinal bleeding and was found to have new right portal vein thrombosis.At an unspecified date the patient experienced encephalopathy.The patient's total bilirubin was 1.0 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 33 mm.The patient's child-pugh score was a.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.The authors assessed the event of severe ascites/abdominal pain, gastrointestinal bleeding, portal vein thrombosis, encephalopathy, biliary ductal dilatation, hematemesis, tumoral bleeding as related to the use of lc bead m1.The author assessed the events of cholecystitis as related to the use of lc bead m1 due to the greater extent of coagulative necrosis induced by smaller drug eluding beads.The authors did not provide an assessment for the events of fatal pneumonia, fatal sepsis, disease progression, mouth sores, decreased oral intake and weakness.The company assessed the events of ascites, abdominal pain, biliary ductal dilatation, hematemesis, tumoral bleeding as serious (medically significant); cholecystitis as serious (intervention required, hospitalization, medically significant); gastrointestinal bleeding, portal vein thrombosis and encephalopathy as serious (hospitalization, medically significant).The company assessed the events of pneumonia, sepsis, stomatitis, hypophagia and asthenia as serious (fatal, hospitalization, medically significant) and the issue of off-label use as non-assessable.The case is linked to case (b)(4) from the same literature article.Follow-up information received on 21-jun-2016: follow-up information has been sought.As of 21-jun-2016, no additional information has been received.Case comment: ascites, abdominal pain, encephalopathy, biliary ductal dilatation, cholecystitis, disease progression, stomatitis, hypophagia, asthenia and off label use of a device are considered unlisted as per lc bead m1 instructions for use.Sepsis, tumoral bleeding, hematemesis, gastrointestinal bleeding are considered listed as per lc bead m1 instructions for use.In agreement with the authors, the company considered the event of ascites, abdominal pain, hematemesis, encephalopathy, biliary ductal dilatation, cholecystitis, tumoral bleeding, portal vein thrombosis, gastrointestinal bleeding and disease progression as related to the device since this possibility cannot be excluded.Of note, the patients' abdominal pain was more likely related to the severe ascites.In absence of the authors' assessment, the company considers the events of sepsis, pneumonia, and stomatitis as related to the device since this possibility cannot be excluded.In absence of the authors' assessment, the company considers the events of hypophagia and asthenia as not related to the use of the device but hypophagia as due to stomatitis, and asthenia due to pneumonia and sepsis.Off-label use of device was considered non-assessable as an event.This single case report does not modify the risk benefit balance of lc bead m1.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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Pneumonia [pneumonia], sepsis [sepsis], severe ascites [ascites], abdominal pain/ right upper quadrant pain [abdominal pain], encephalopathy [encephalopathy], biliary ductal dilatation [biliary dilatation], mrecist evaluation revealed progressive disease (pd) [disease progression], mouth sores [stomatitis], decreased oral intake [hypophagia], weakness [asthenia], cholecystitis [cholecystitis], right portal vein thrombosis [portal vein thrombosis], hematemesis [haematemesis], tumoral bleeding [tumour haemorrhage], gastrointestinal bleeding [gastrointestinal haemorrhage], loaded with 50 mg of doxorubicin [off label use of device].Case description: initial information received on 18-may-2016: this literature case report was published in 2015 in the journal of vascular and interventional radiology by deipolyi ar et al.With the title "safety and efficacy of 70-150 microm and 100-300 microm drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma" and concerning 13 patients.The patients' medical history included hepatocellular carcinoma.No information concerning concomitant medication was provided.Between (b)(6) 2012 and (b)(6) 2013, the patients in group 2 received one vial of 70-150 microm lc bead m1 loaded with 50 mg of doxorubicin which was followed by one vial of 100-300 microm lc bead m1 loaded with 50 mg of doxorubicin as transarterial chemoembolization for unresectable hepatocellular carcinoma (hcc).On an unspecified date, a (b)(6) male patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 2.0 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 16 mm.The patient's child-pugh score was b.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, an (b)(6) male patient experienced encephalopathy and biliary ductal dilatation.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 31 mm.The patient's child-pugh score was a.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) female patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 1.4 mg/dl approximately 2 days prior to the procedure.Her index lesion was measured as 50 mm.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing into left lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) female patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.4 mg/dl approximately 2 days prior to the procedure.Her index lesion was measured as 14 mm.The patient's child-pugh score was a.This patient received her transarterial chemoembolization dosing selectively.The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with additional relevant medical history of (b)(6) experienced hematemesis.The patient's total bilirubin was 3.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 51 mm.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing selectively.The outcome of the event is unknown.On an unspecified date, an (b)(6) female patient experienced tumoral bleeding.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.The patient's child-pugh score was b.This patient received her transarterial chemoembolization dosing selectively.The outcome of the event is unknown.On an unspecified date, within one month of treatment, a (b)(6) female patient with additional relevant medical history of primary biliary cirrhosis died at an outside hospital from pneumonia and sepsis after a re-admission for severe ascites, mouth sores, decreased oral intake, right upper quadrant pain and weakness.The patient's total bilirubin was 0.7 mg/dl approximately 2 days prior to the procedure.The patient's child-pugh score was a.The outcomes of the events of severe ascites, mouth sores, decreased oral intake, right upper quadrant pain and weakness at the time of death was unknown.The cause of death was noted as pneumonia and sepsis.On an unspecified date, an (b)(6) female patient with additional relevant medical history of nonalcoholic steatohepatitis (nash) experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.7 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 31 mm.The patient's child-pugh score was a.This patient received this dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 2.5 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 64 mm.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).This patient received his transarterial chemoembolization dosing bilobar.The outcomes of the events are unknown.On an unspecified date, the (b)(6) female patient with additional relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 71 mm.The patient's child-pugh score was a.This patient received this dosing into right lobe.The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with additional relevant medical history of (b)(6) experienced cholecystitis.Treatment included a cholecystectomy at an outside institution.The patient's total bilirubin was 1.9 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 28 mm.The patient's child-pugh score was a.This patient received the dosing into the right lobe.The outcome of the event is unknown.On an unspecified date, a (b)(6) female patient with additional relevant medical history of (b)(6) experienced acute cholecystitis.The patient's total bilirubin was 0.3 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 10 mm.Overnight, following treatment, the patient experienced severe right upper quadrant pain and was found to have acute cholecystitis on ct scan.This patient received this dosing into the right hepatic artery.Injection through the microcatheter positioned for treatment showed an opacification of the cystic artery.Treatment was managed conservatively with resolution of the cholecystitis.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).The outcomes of the events are unknown.On an unspecified date, after discharge, a (b)(6) male patient with additional relevant medical history of alcohol abuse (etoh) presented to the emergency department with gastrointestinal bleeding and was found to have new right portal vein thrombosis.At an unspecified date the patient experienced encephalopathy.The patient's total bilirubin was 1.0 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 33 mm.The patient's child-pugh score was a.The patient received his transarterial chemoembolization dosing into right lobe.The outcomes of the events are unknown.The authors assessed the event of severe ascites/abdominal pain, gastrointestinal bleeding, portal vein thrombosis, encephalopathy, biliary ductal dilatation, hematemesis, tumoral bleeding as related to the use of lc bead m1.The author assessed the events of cholecystitis as related to the use of lc bead m1 due to the greater extent of coagulative necrosis induced by smaller drug eluding beads.The authors did not provide an assessment for the events of fatal pneumonia, fatal sepsis, disease progression, mouth sores, decreased oral intake and weakness.The company assessed the events of ascites, abdominal pain, biliary ductal dilatation, hematemesis, tumoral bleeding as serious (medically significant); cholecystitis as serious (intervention required, hospitalization, medically significant); gastrointestinal bleeding, portal vein thrombosis and encephalopathy as serious (hospitalization, medically significant).The company assessed the events of pneumonia, sepsis, stomatitis, hypophagia and asthenia as serious (fatal, hospitalization, medically significant) and the issue of off-label use as non-assessable.The case is linked to case (b)(4) from the same literature article.Follow-up information received on 21-jun-2016: follow-up information has been sought.As of 21-jun-2016, no additional information has been received.Follow-up information received on 22-jul-2016: follow-up information was requested to further investigate the event but no new information has been received.No device failure has been identified as a result of this adverse event.It has been assessed that no corrective action is necessary at this time.The report is final.Case comment: ascites, abdominal pain, encephalopathy, biliary ductal dilatation, cholecystitis, disease progression, stomatitis, hypophagia, asthenia and off label use of a device are considered unlisted as per lc bead m1 instructions for use.Sepsis, tumoral bleeding, hematemesis, gastrointestinal bleeding are considered listed as per lc bead m1 instructions for use.In agreement with the authors, the company considered the event of ascites, abdominal pain, hematemesis, encephalopathy, biliary ductal dilatation, cholecystitis, tumoral bleeding, portal vein thrombosis, gastrointestinal bleeding and disease progression as related to the device since this possibility cannot be excluded.Of note, the patients' abdominal pain was more likely related to the severe ascites.In absence of the authors' assessment, the company considers the events of sepsis, pneumonia, and stomatitis as related to the device since this possibility cannot be excluded.In absence of the authors' assessment, the company considers the events of hypophagia and asthenia as not related to the use of the device but hypophagia as due to stomatitis, and asthenia due to pneumonia and sepsis.Off-label use of device was considered non-assessable as an event.This single case report does not modify the risk benefit balance of lc bead m1.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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Search Alerts/Recalls
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