| Model Number UNKNOWN |
| Device Problem
Off-Label Use (1494)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Death
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Manufacturer Narrative
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Dc bead (with epirubicin) was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
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Event Description
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Hepatic abscess grade 5 [liver abscess].Multi-resistant klebsiella spp.Sepsis [klebsiella sepsis].Progressive disease [disease progression].1 non-target sub-segmental artery embolization [device deployment issue].Partial response [therapeutic response decreased].Epirubicin-preloaded [off label use of device].Case description: initial information received on 17-jan-2017: this literature device report was published in cirse 2016 by lucatelli p.Et al., entitled "hypervascular hcc tace performed with m1 dc bead: first long-term follow-up results", concerning 39 patients (gender: 29 males and 10 females) with a mean age of 67.4 +/-13.3 years.The patients' medical history included typical hypervascular hepatocellular carcinoma (hcc).All cases were not fit for surgery.The indications, based on mdct/mr scans, were bclc-a (n=17) and bclc-b (n=22).The patients' concomitant medications were not reported.On an unspecified date, between 2014 and 2015, 49 typical hypervascular hcc in 39 patients were prospectively enrolled in the study.On an unspecified date, between 2014 and 2015, a total of 49 transarterial chemoembolization (tace), with drug eluting beads preloaded with 100 mg of epirubicin divided in vials of 75-150 microm and 100-300 microm particles was performed (lot numbers and expiration dates not reported), for hypervascular hcc.The tace procedure was highly standardized: cone beam ct-assisted procedure with superselective microcatheterization (2.7 fr).The following embolization protocol was used: m1 particles were injected first; only if arterial flow arrest was not achieved, 150-300 particles were injected till stasis.Procedures were categorized according to a novel score identifying the degree of superselective microcatheterization achieved.Results were evaluated, according to mrecist criteria, on mdct/mri at 1 month, 3/6 months and 9/12 months.On an unspecified date, 30 tace cases experienced "1 non-target sub-segmental artery embolization".The outcome of the event was unknown.On an unspecified date, at 1 month follow-up, the following was observed: complete response (cr), 51%; partial response (pr), 46.9%; stable disease (sd), 2.1% and objective response (or), 97.9%.On an unspecified date, at 3-6-month follow-up, cr was 33.3%, progressive disease (pd) 42.2%, sd 24.4% and or 75.5%.On an unspecified date, at 9-2-month follow-up, cr was 47.2%, sd 41.6% pd 1% (in 11) and or 88.8%.The outcome of pr and pd was unknown.In the follow-up period, 10 patients required a second tace, and no complication was observed.The reporting author did not provide an assessment of the events seriousness or events causality to the dc bead/dc bead m1, but mentioned that tace with 70-150 microm dc bead m1 provided excellent long-term control of hcc burden, with a few treatment sessions.The company considered the events non-target sub-segmental artery embolization and progressive disease as serious (medically significant), and the event partial response as non-serious.Follow-up information will be requested.Follow-up information received on 06-feb-2017 and additional information received on 16-feb-2017: follow-up information was received from the reporting author.On an unknown date, during the enrollment period, one major complication was experienced.The details (onset date, number of patients involved, treatment, outcome, and resolution date) were not reported.The reporting author did not provide an assessment of the event seriousness, but considered the major complication related to dc bead/dc bead m1.Additionally, the reporter considered that the event non-target sub-segmental artery embolization did not correlate to complications or adverse events.The reporter stated that this was referred to a special classification (in course of publication) of the typology of the embolization procedure.The company considered the event major complication serious (medically significant).Follow-up information will be requested.Risk assessment: the overall post-market ae reporting rate for dc bead across all indications for use is 0.14%.This rate is calculated from the total number of spontaneous ae reports divided by number of dc bead treatments (an estimate based on cumulative sales data of dc bead and lc bead) during the same interval.Since approval, 328 spontaneous ae reports for dc bead have been received by biocompatibles uk ltd from the marketplace or from the published literature.It is estimated that 225,513 treatments have been performed with dc bead since its initial approval.This exposure calculation is based on a total of 451,026 vials of product sold and on the assumption that an average of 2 vials of product were used per patient treatment.It should be noted that some patients receive multiple treatments and therefore this is not an estimate of the actual number of patients treated.The number of aes reported year on year has been assessed for trending purposes.While an increase of reports has been seen this is directly correlated to the increased sales volume.Despite the increase of ae reports, the reporting rates remain extremely low (0.14%).The medical assessment of this case concluded that the events reported were either known harms related to treatment (and listed in the potential complications of the ifu) or were likely to be related to progression of the patient's underlying condition.Dc bead is indicated as a palliative treatment and is not expected to be curative.For this reason, disease progression is a natural consequence of the patient's underlying disease state.The overall conclusion was that this report does not identify any event that would require any corrective action on the part of the manufacturer.Number of devices supplied in the (b)(4) in 2007.Follow-up information received on 04-mar-2017: follow-up information was received from the reporting author.The only major adverse event (grade 5) was a case of hepatic abscess, which led to patient death due to multi-resistant klebsiella spp.Sepsis.The patient's age and gender were not reported.The patient's medical history included portal hypertension, primitive biliary cirrhosis, transjugular intrahepatic porto-systemic shunt (tips) to treat esophageal varices and left biliary drainage and cholangioscopy in order to diagnose the nature of the stenosis causing an indolent (bilirubine 1,8 mg/dl) left lobe biliary system dilation.The reporting author stated that these two factors: the flow diversion caused by tips and the not sterile biliary tree due to the previous percutaneous procedure, predisposed the patient to complication onset.The procedure was performed because the patient was child pugh b7 score and a bclc b stage so fit for enrollment.The reporting author assessed the events hepatic abscess and multi-resistant klebsiella spp.Sepsis to be serious (fatal) and related to dc bead/dc bead m1.The company considered the event hepatic abscess and multi-resistant klebsiella spp.Sepsis to be serious (fatal).Follow-up information will be requested.Additional information on 03-apr-2017: follow up information has been sought to further investigate the events but no new information has been received.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 comment: liver abscess, klebsiella sepsis, device deployment issue, therapeutic response decreased and complication associated with device are considered listed according to dc bead/dc bead m1 current reference safety information, whereas disease progression and off label use of device are unlisted.In agreement with the reporter, the company considered the events liver abscess and klebsiella sepsis related to the use of dc bead/dc bead m1.However, low diversion caused by tips and the not sterile biliary tree due to the previous percutaneous procedure may have predisposed the patient to these events.In disagreement with the reporter, the company considered device deployment issue related to the use of dc bead/dc bead m1.Disease progression is part of the disease process and partial response can be expected in the course of the patient condition and treatment, thus the company considered therapeutic response decreased not related to dc bead/dc bead m1.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 dc bead/dc 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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Manufacturer Narrative
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Dc bead (with epirubicin) was reported to have been used in the treatment of these patients.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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Progressive disease [disease progression].1 non-target sub-segmental artery embolization [device deployment issue].Partial response [therapeutic response decreased].Epirubicin-preloaded [off label use of device].Case description: initial information received on 17-jan-2017: this literature device report was published in cirse 2016 by lucatelli p.Et al., entitled "hypervascular hcc tace performed with m1 dc bead: first long-term follow-up results", concerning 39 patients (gender: 29 males and 10 females) with a mean age of 67.4 +/-13.3 years.The patients' medical history included typical hypervascular hepatocellular carcinoma (hcc).All cases were not fit for surgery.The indications, based on mdct/mr scans, were bclc-a (n=17) and bclc-b (n=22).The patients' concomitant medications were not reported.On an unspecified date, between 2014 and 2015, 49 typical hypervascular hcc in 39 patients were prospectively enrolled in the study.On an unspecified date, between 2014 and 2015, a total of 49 transarterial chemoembolization (tace), with drug eluting beads preloaded with 100 mg of epirubicin divided in vials of 75-150 microm and 100-300 microm particles was performed (lot numbers and expiration dates not reported), for hypervascular hcc.The tace procedure was highly standardized: cone beam ct-assisted procedure with superselective microcatheterization (2.7 fr).The following embolization protocol was used: m1 particles were injected first; only if arterial flow arrest was not achieved, 150-300 particles were injected till stasis.Procedures were categorized according to a novel score identifying the degree of superselective microcatheterization achieved.Results were evaluated, according to mrecist criteria, on mdct/mri at 1 month, 3/6 months and 9/12 months.On an unspecified date, 30 tace cases experienced "1 non-target sub-segmental artery embolization".The outcome of the event was unknown.On an unspecified date, at 1 month follow-up, the following was observed: complete response (cr), 51%; partial response (pr), 46.9%; stable disease (sd), 2.1% and objective response (or), 97.9%.On an unspecified date, at 3-6-month follow-up, cr was 33.3%, progressive disease (pd) 42.2%, sd 24.4% and or 75.5%.On an unspecified date, at 9-2-month follow-up, cr was 47.2%, sd 41.6% pd 1% (in 11) and or 88.8%.The outcome of pr and pd was unknown.In the follow-up period, 10 patients required a second tace, and no complication was observed.The reporting author did not provide an assessment of the events seriousness or events causality to the dc bead/dc bead m1, but mentioned that tace with 70-150 microm dc bead m1 provided excellent long-term control of hcc burden, with a few treatment sessions.The company considered the events non-target sub-segmental artery embolization and progressive disease as serious (medically significant), and the event partial response as non-serious.Follow-up information will be requested.Case comment: device deployment issue and therapeutic response decreased are considered listed according to dc bead/dc bead m1 current reference safety information whereas disease progression and off label use of device are unlisted.In absence of an assessment made by the reporter, the company considered the event device deployment issue related to the use of dc bead/dc bead m1.Disease progression is part of the disease process and partial response can be expected in the course of the patient condition and treatment, thus the company considered therapeutic response decreased not related to dc bead/dc bead m1.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 dc bead/dc 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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Manufacturer Narrative
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Dc bead (with epirubicin) was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
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Event Description
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Hepatic abscess grade 5 [liver abscess], multi-resistant klebsiella spp.Sepsis [klebsiella sepsis], progressive disease [disease progression], 1 non-target sub-segmental artery embolization [device deployment issue], partial response [therapeutic response decreased], epirubicin-preloaded [off label use of device].Case description: initial information received on 17-jan-2017: this literature device report was published in cirse 2016 by lucatelli p.Et al., entitled "hypervascular hcc tace performed with m1 dc bead: first long-term follow-up results", concerning 39 patients (gender: 29 males and 10 females) with a mean age of 67.4 +/-13.3 years.The patients' medical history included typical hypervascular hepatocellular carcinoma (hcc).All cases were not fit for surgery.The indications, based on mdct/mr scans, were bclc-a (n=17) and bclc-b (n=22).The patients' concomitant medications were not reported.On an unspecified date, between 2014 and 2015, 49 typical hypervascular hcc in 39 patients were prospectively enrolled in the study.On an unspecified date, between 2014 and 2015, a total of 49 transarterial chemoembolization (tace), with drug eluting beads preloaded with 100 mg of epirubicin divided in vials of 75-150 microm and 100-300 microm particles was performed (lot numbers and expiration dates not reported), for hypervascular hcc.The tace procedure was highly standardized: cone beam ct-assisted procedure with superselective microcatheterization (2.7 fr).The following embolization protocol was used: m1 particles were injected first; only if arterial flow arrest was not achieved, 150-300 particles were injected till stasis.Procedures were categorized according to a novel score identifying the degree of superselective microcatheterization achieved.Results were evaluated, according to mrecist criteria, on mdct/mri at 1 month, 3/6 months and 9/12 months.On an unspecified date, 30 tace cases experienced "1 non-target sub-segmental artery embolization".The outcome of the event was unknown.On an unspecified date, at 1 month follow-up, the following was observed: complete response (cr), 51%; partial response (pr), 46.9%; stable disease (sd), 2.1% and objective response (or), 97.9%.On an unspecified date, at 3-6-month follow-up, cr was 33.3%, progressive disease (pd) 42.2%, sd 24.4% and or 75.5%.On an unspecified date, at 9-2-month follow-up, cr was 47.2%, sd 41.6% pd 1% (in 11) and or 88.8%.The outcome of pr and pd was unknown.In the follow-up period, 10 patients required a second tace, and no complication was observed.The reporting author did not provide an assessment of the events seriousness or events causality to the dc bead/dc bead m1, but mentioned that tace with 70-150 microm dc bead m1 provided excellent long-term control of hcc burden, with a few treatment sessions.The company considered the events non-target sub-segmental artery embolization and progressive disease as serious (medically significant), and the event partial response as non-serious.Follow-up information will be requested.Follow-up information received on 06-feb-2017 and additional information received on 16-feb-2017: follow-up information was received from the reporting author.On an unknown date, during the enrollment period, one major complication was experienced.The details (onset date, number of patients involved, treatment, outcome, and resolution date) were not reported.The reporting author did not provide an assessment of the event seriousness, but considered the major complication related to dc bead/dc bead m1.Additionally, the reporter considered that the event non-target subsegmental artery embolization did not correlate to complications or adverse events.The reporter stated that this was referred to a special classification (in course of publication) of the typology of the embolization procedure.The company considered the event major complication serious (medically significant).Follow-up information will be requested.Risk assessment: (b)(4).This rate is calculated from the total number of spontaneous ae reports divided by number of dc bead treatments (an estimate based on cumulative sales data of dc bead and lc bead) during the same interval.Since approval, 328 spontaneous ae reports for dc bead have been received by biocompatibles uk ltd from the marketplace or from the published literature.It is estimated that 225,513 treatments have been performed with dc bead since its initial approval.This exposure calculation is based on a total of (b)(4) of product sold and on the assumption that an average of 2 vials of product were used per patient treatment.It should be noted that some patients receive multiple treatments and therefore this is not an estimate of the actual number of patients treated.The number of aes reported year on year has been assessed for trending purposes.While an increase of reports has been seen this is directly correlated to the increased sales volume.Despite the increase of ae reports, (b)(4).The medical assessment of this case concluded that the events reported were either known harms related to treatment (and listed in the potential complications of the ifu) or were likely to be related to progression of the patient's underlying condition.Dc bead is indicated as a palliative treatment and is not expected to be curative.For this reason, disease progression is a natural consequence of the patient's underlying disease state.The overall conclusion was that this report does not identify any event that would require any corrective action on the part of the manufacturer.Number of devices supplied in the uk, eu and world-wide (last 3 years): uk: 0 (2014); 1009 (2015); 1442 (2016) eu: 25212 (2014); 11050 (2015); 9598 (2016) row: 46270 (2014); 25637 (2015); 42745 (2016) total: 71482 (2014); 37696 (2015); 53785 (2016) date when device was first supplied in the uk: dc bead was commercially launched in the uk in 2007.Follow-up information received on 04-mar-2017: follow-up information was received from the reporting author.The only major adverse event (grade 5) was a case of hepatic abscess, which led to patient death due to multi-resistant klebsiella spp.Sepsis.The patient's age and gender were not reported.The patient's medical history included portal hypertension, primitive biliary cirrhosis, transjugular intrahepatic porto-systemic shunt (tips) to treat esophageal varices and left biliary drainage and cholangioscopy in order to diagnose the nature of the stenosis causing an indolent (bilirubine 1,8 mg/dl) left lobe biliary system dilation.The reporting author stated that these two factors: the flow diversion caused by tips and the not sterile biliary tree due to the previous percutaneous procedure, predisposed the patient to complication onset.The procedure was performed because the patient was child pugh b7 score and a bclc b stage so fit for enrollment.The reporting author assessed the events hepatic abscess and multi-resistant klebsiella spp.Sepsis to be serious (fatal) and related to dc bead/dc bead m1.The company considered the event hepatic abscess and multi-resistant klebsiella spp.Sepsis to be serious (fatal).Follow-up information will be requested.Case comment: liver abscess, klebsiella sepsis, device deployment issue, therapeutic response decreased and complication associated with device are considered listed according to dc bead/dc bead m1 current reference safety information, whereas disease progression and off label use of device are unlisted.In agreement with the reporter, the company considered the events liver abscess and klebsiella sepsis related to the use of dc bead/dc bead m1.However, low diversion caused by tips and the not sterile biliary tree due to the previous percutaneous procedure may have predisposed the patient to these events.In disagreement with the reporter, the company considered device deployment issue related to the use of dc bead/dc bead m1.Disease progression is part of the disease process and partial response can be expected in the course of the patient condition and treatment, thus the company considered therapeutic response decreased not related to dc bead/dc bead m1.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 dc bead/dc 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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Manufacturer Narrative
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|
Dc bead (with epirubicin) was reported to have been used in the treatment of these patients.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
|
| |
|
Event Description
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|
Progressive disease [disease progression], 1 non-target sub-segmental artery embolization [device deployment issue], partial response [therapeutic response decreased], epirubicin-preloaded [off label use of device].Case description: initial information received on 17-jan-2017: this literature device report was published in cirse 2016 by lucatelli p.Et al., entitled "hypervascular hcc tace performed with m1 dc bead: first long-term follow-up results", concerning 39 patients (gender: 29 males and 10 females) with a mean age of 67.4 +/-13.3 years.The patients' medical history included typical hypervascular hepatocellular carcinoma (hcc).All cases were not fit for surgery.The indications, based on mdct/mr scans, were bclc-a (n=17) and bclc-b (n=22).The patients' concomitant medications were not reported.On an unspecified date, between 2014 and 2015, 49 typical hypervascular hcc in 39 patients were prospectively enrolled in the study.On an unspecified date, between 2014 and 2015, a total of 49 transarterial chemoembolization (tace), with drug eluting beads preloaded with 100 mg of epirubicin divided in vials of 75-150 microm and 100-300 microm particles was performed (lot numbers and expiration dates not reported), for hypervascular hcc.The tace procedure was highly standardized: cone beam ct-assisted procedure with superselective microcatheterization (2.7 fr).The following embolization protocol was used: m1 particles were injected first; only if arterial flow arrest was not achieved, 150-300 particles were injected till stasis.Procedures were categorized according to a novel score identifying the degree of superselective microcatheterization achieved.Results were evaluated, according to mrecist criteria, on mdct/mri at 1 month, 3/6 months and 9/12 months.On an unspecified date, 30 tace cases experienced "1 non-target sub-segmental artery embolization".The outcome of the event was unknown.On an unspecified date, at 1 month follow-up, the following was observed: complete response (cr), 51%; partial response (pr), 46.9%; stable disease (sd), 2.1% and objective response (or), 97.9%.On an unspecified date, at 3-6-month follow-up, cr was 33.3%, progressive disease (pd) 42.2%, sd 24.4% and or 75.5%.On an unspecified date, at 9-2-month follow-up, cr was 47.2%, sd 41.6% pd 1% (in 11) and or 88.8%.The outcome of pr and pd was unknown.In the follow-up period, 10 patients required a second tace, and no complication was observed.The reporting author did not provide an assessment of the events seriousness or events causality to the dc bead/dc bead m1, but mentioned that tace with 70-150 microm dc bead m1 provided excellent long-term control of hcc burden, with a few treatment sessions.The company considered the events non-target sub-segmental artery embolization and progressive disease as serious (medically significant), and the event partial response as non-serious.Follow-up information will be requested.Follow-up information received on 06-feb-2017 and additional information received on 16-feb-2017: follow-up information was received from the reporting author.On an unknown date, during the enrollment period, one major complication was experienced.The details (onset date, number of patients involved, treatment, outcome, and resolution date) were not reported.The reporting author did not provide an assessment of the event seriousness, but considered the major complication related to dc bead/dc bead m1.Additionally, the reporter considered that the event non-target sub-segmental artery embolization did not correlate to complications or adverse events.The reporter stated that this was referred to a special classification (in course of publication) of the typology of the embolization procedure.The company considered the event major complication serious (medically significant).Follow-up information will be requested.Risk assessment: (b)(4).This rate is calculated from the total number of spontaneous ae reports divided by number of dc bead treatments (an estimate based on cumulative sales data of dc.Bead and lc bead) during the same interval.Since approval, 328 spontaneous ae reports for dc bead have been received by biocompatibles uk ltd from the marketplace or from the published literature.It is estimated that 225,513 treatments have been performed with dc bead since its initial approval.This exposure calculation is based on a total of (b)(4) of product sold and on the assumption that an average of 2 vials of product were used per patient treatment.It should be noted that some patients receive multiple treatments and therefore this is not an estimate of the actual number of patients treated.The number of aes reported year on year has been assessed for trending purposes.While an increase of reports has been seen this is directly correlated to the increased sales volume.(b)(4).The medical assessment of this case concluded that the events reported were either known harms related to treatment (and listed in the potential complications of the ifu) or were likely to be related to progression of the patient's underlying condition.Dc bead is indicated as a palliative treatment and is not expected to be curative.For this reason, disease progression is a natural consequence of the patient's underlying disease state.The overall conclusion was that this report does not identify any event that would require any corrective action on the part of the manufacturer.Number of devices supplied in the uk, eu and world-wide (last 3 years): uk: 0 (2014); 1009 (2015); 1442 (2016).Eu: 25212 (2014); 11050 (2015); 9598 (2016).Row: 46270 (2014); 25637 (2015); 42745 (2016).Total: 71482 (2014); 37696 (2015); 53785 (2016).Date when device was first supplied in the uk: dc bead was commercially launched in the uk in 2007.Case comment: device deployment issue, therapeutic response decreased and complication associated with device are considered listed according to dc bead/dc bead m1 current reference safety information, whereas disease progression and off label use of device are unlisted.In agreement with the reporter, the company considered the event complication associated with device related to the use of dc bead/dc bead m1.However, in disagreement with the reporter, the company considered device deployment issue related to the use of dc bead/dc bead m1.Disease progression is part of the disease process and partial response can be expected in the course of the patient condition and treatment, thus the company considered therapeutic response decreased not related to dc bead/dc bead m1.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 dc bead/dc 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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