| Model Number 100-300 UM |
| Device Problem
Activation, Positioning or Separation Problem (2906)
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| Patient Problems
Death (1802); Edema (1820); Gangrene (1873); Necrosis (1971); Vomiting (2144)
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| Event Date 08/19/2014 |
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Event Type
Death
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Manufacturer Narrative
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Dc bead was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
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Event Description
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Hepatic failure.Disease progression.] gangrenous cholecystitis.Drug-eluting bead in gallbladder wall arteries/ non-target embolization [device deployment issue].Device loaded with epirubicin [off label use of device].Case description: initial information received on 21-dec-2016: this literature case report was published in 2016 in an unspecified journal by kusakabe m, et al with the title " a case of gangrenous cholecystitis after transarterial chemoembolization with drug-eluting beads" regarding a (b)(6) male patient.Medical history included liver cirrhosis caused by hepatitis b, multiple hepatocellular carcinomas (ct3, n0, m0, stage iii) with the largest tumour of 30 mm at the medial segment (s4), and previous transcatheter arterial chemoembolization (tace) using gelatin sponge for a total of 5 times during the period of 7 months after the initial admission.This kept the patient in a stable condition.In the previous tace procedures, embolization was performed through the medial branch of the left hepatic artery.Other concomitant medications were not provided.The patient received dc beads for his sixth session of tace on an unspecified date.A total of 20 ml of suspension containing 100-300 mcm 1a of dc beads, 50 mg of epirubicin, 2 ml of injection solvent, 9 ml of heparin saline, and 9 ml of iomeron (contrast agent) was prepared and injected intra-arterially.Post-tace angiography revealed and confirmed disappearance of tumor stain in s4.At an unspecified date, immediately after completion of sixth tace session, the patient vomited and developed persisting right hypochondralgia.An emergently performed computed tomography (ct) scan of the abdomen revealed acute cholecystitis associated with embolization of peripheral cholecystic artery.Treatment included surgery.The operative notes provided: operation was initiated in a supine position under general anesthesia; ports were placed in a total of 4 sites in the umbilical region, left lower abdomen, and right hypochondriac region: and a laparoscopic cholecystectomy was performed.Laparoscopic observation revealed necrosis of the gallbladder wall and hepatocellular carcinoma (hcc) in the s4 region.The hcc adhered to the omental and duodenum.The cervix of the gallbladder was exposed and the entire circumference of the serosa of the gallbladder was separated, and then the cystic duct and cystic artery were identified.The cystic artery was white in color and not beating.The artery was clipped and dissected, and then the gallbladder was removed.The surgical time was 1 hour and 52 minutes, with little loss of blood.The histopathological findings were: the wall of resected gallbladder was fragile with change in color; in all layers of the gallbladder wall, edema, degenerative necrosis, and lymphocytic infiltration were noted; a number of drug-eluting beads were noted in the arteries of the gallbladder wall; and fibrin formation was noted around the embolic material.The pathological diagnosis was gangrenous cholecystitis.Postoperative clinical course was uneventful.The patient was discharged to home on the eighth hospital day with planned outpatient follow-up.After discharge, two more sessions of tace were performed for hcc on unspecified dates.However, the patient experienced disease progression and hepatic failure and died 6 months after the operation.The physician author assessed the gangrenous cholecystitis as probably related to the use of dc bead and assessed fatal hepatic failure as not related to the use of dc bead.The author did not provide assessment for the events of non-target embolization and off label use of a device to the use of dc beads.The physician also commented, "in this case, acute cholecystitis was considered to be caused by embolization of the cystic artery while dcb was injected into the right hepatic artery branch." the company assessed the events of hepatic failure (fatal), disease progression (fatal), gangrenous cholecystitis ( hospitalization, required intervention) and drug-eluting bead in gallbladder wall arteries/ non-target embolization ( hospitalization, required intervention) as serious.Follow up will be attempted.Case comment: hepatic failure and disease progression are considered unlisted as per dc beads instructions for use, however are expected in patients with liver cancer.Gangrenous cholecystitis and non-target embolization are listed.In agreement with the authors and due to the strong temporal relationship, the company considers the events of gangrenous cholecystitis and device deployment issue are related to treatment with dc beads.In agreement with the authors, the company considers the event of hepatic failure as not related to the dc bead but in absence of the author's assessment, the company considers the event of fatal disease progression as not related to treatment with dc bead.Off label use of device (device loaded with epirubicin) is not considered an adverse event per se but as a special scenario and thus not assessable as an adverse event.This single case report does not modify the risk benefit balance of dc 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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Manufacturer Narrative
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Dc bead was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
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Event Description
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Hepatic failure.Disease progression.Gangrenous cholecystitis.Drug-eluting bead in gallbladder wall arteries/ non-target embolization [device deployment issue].Device loaded with epirubicin [off label use of device].Case description: initial information received on 21-dec-2016: this literature case report was published in 2016 in an unspecified journal by kusakabe m, et al with the title " a case of gangrenous cholecystitis after transarterial chemoembolization with drug-eluting beads" regarding a (b)(6) male patient.Medical history included liver cirrhosis caused by (b)(6), multiple hepatocellular carcinomas (ct3, n0, m0, stage iii) with the largest tumour of 30 mm at the medial segment (s4), and previous transcatheter arterial chemoembolization (tace) using gelatin sponge for a total of 5 times during the period of 7 months after the initial admission.This kept the patient in a stable condition.In the previous tace procedures, embolization was performed through the medial branch of the left hepatic artery.Other concomitant medications were not provided.The patient received dc beads for his sixth session of tace on an unspecified date.A total of 20 ml of suspension containing 100-300 mcm 1a of dc beads, 50 mg of epirubicin, 2 ml of injection solvent, 9 ml of heparin saline, and 9 ml of iomeron (contrast agent) was prepared and injected intra-arterially.Post-tace angiography revealed and confirmed disappearance of tumor stain in s4.At an unspecified date, immediately after completion of sixth tace session, the patient vomited and developed persisting right hypochondralgia.An emergently performed computed tomography (ct) scan of the abdomen revealed acute cholecystitis associated with embolization of peripheral cholecystic artery.Treatment included surgery.The operative notes provided: operation was initiated in a supine position under general anesthesia; ports were placed in a total of 4 sites in the umbilical region, left lower abdomen, and right hypochondriac region: and a laparoscopic cholecystectomy was performed.Laparoscopic observation revealed necrosis of the gallbladder wall and hepatocellular carcinoma (hcc) in the s4 region.The hcc adhered to the omental and duodenum.The cervix of the gallbladder was exposed and the entire circumference of the serosa of the gallbladder was separated, and then the cystic duct and cystic artery were identified.The cystic artery was white in color and not beating.The artery was clipped and dissected, and then the gallbladder was removed.The surgical time was 1 hour and 52 minutes, with little loss of blood.The histopathological findings were: the wall of resected gallbladder was fragile with change in color; in all layers of the gallbladder wall, edema, degenerative necrosis, and lymphocytic infiltration were noted; a number of drug-eluting beads were noted in the arteries of the gallbladder wall; and fibrin formation was noted around the embolic material.The pathological diagnosis was gangrenous cholecystitis.Postoperative clinical course was uneventful.The patient was discharged to home on the eighth hospital day with planned outpatient follow-up.After discharge, two more sessions of tace were performed for hcc on unspecified dates.However, the patient experienced disease progression and hepatic failure and died 6 months after the operation.The physician author assessed the gangrenous cholecystitis as probably related to the use of dc bead and assessed fatal hepatic failure as not related to the use of dc bead.The author did not provide assessment for the events of non-target embolization and off label use of a device to the use of dc beads.The physician also commented, "in this case, acute cholecystitis was considered to be caused by embolization of the cystic artery while dcb was injected into the right hepatic artery branch." the company assessed the events of hepatic failure (fatal), disease progression (fatal), gangrenous cholecystitis ( hospitalization, required intervention) and drug-eluting bead in gallbladder wall arteries/ non-target embolization ( hospitalization, required intervention) as serious.Follow up will be attempted.Follow-up information was received on 18-jan-2017: follow-up information was received from the author via the company distributor.Additional medical history included a child-pugh classification of class b; and a correction in the maximum tumor diameter from 30 mm to 25 mm.Also additional details regarding the tace procedure included the degree of embolization for the disappearance rate of contrast medium was 5 heartbeats after contrast medium injection.There was also a presence of collateral circulation at the arterial branches in the right anterior segment of the liver which were noted to be feeding the hcc tumour in s4 segment.On (b)(6) 2014, the patient experienced gangrenous cholecystitis following a tace procedure using 1 vial of dc beads (100-300 mcm) loaded with 50 mg epirubicin.On (b)(6) 2014, a laparoscopic cholecystectomy was performed.On (b)(6) 2014, the patient was discharged home on the eighth hospital day.On an unspecified date, the patient was recovering from the gangrenous cholecystitis.On (b)(6) 2015, 6 months after the operation due to gangrenous cholecystitis, the patient died from disease progression and hepatic failure.Additional information is expected.Case comment: hepatic failure and disease progression are considered unlisted as per dc beads instructions for use, however are expected in patients with liver cancer.Gangrenous cholecystitis and non-target embolization are listed.In agreement with the authors and due to the strong temporal relationship, the company considers the events of gangrenous cholecystitis and device deployment issue are related to treatment with dc beads.In agreement with the authors, the company considers the event of hepatic failure as not related to the dc bead but in absence of the author's assessment, the company considers the event of fatal disease progression as not related to treatment with dc bead.Off label use of device (device loaded with epirubicin) is not considered an adverse event per se but as a special scenario and thus not assessable as an adverse event.This single case report does not modify the risk benefit balance of dc 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.
|
| |
|
Manufacturer Narrative
|
|
Dc bead was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
|
| |
|
Event Description
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|
Hepatic failure.Disease progression.Gangrenous cholecystitis.Drug-eluting bead in gallbladder wall arteries/ non-target embolization [device deployment issue].Device loaded with epirubicin [off label use of device].Case description: initial information received on 21-dec-2016: this literature case report was published in 2016 in an unspecified journal by kusakabe m, et al with the title " a case of gangrenous cholecystitis after transarterial chemoembolization with drug-eluting beads" regarding a (b)(6) male patient.Medical history included liver cirrhosis caused by hepatitis b, multiple hepatocellular carcinomas (ct3, n0, m0, stage iii) with the largest tumour of 30 mm at the medial segment (s4), and previous transcatheter arterial chemoembolization (tace) using gelatin sponge for a total of 5 times during the period of 7 months after the initial admission.This kept the patient in a stable condition.In the previous tace procedures, embolization was performed through the medial branch of the left hepatic artery.Other concomitant medications were not provided.The patient received dc beads for his sixth session of tace on an unspecified date.A total of 20 ml of suspension containing 100-300 mcm 1a of dc beads, 50 mg of epirubicin, 2 ml of injection solvent, 9 ml of heparin saline, and 9 ml of iomeron (contrast agent) was prepared and injected intra-arterially.Post-tace angiography revealed and confirmed disappearance of tumor stain in s4.At an unspecified date, immediately after completion of sixth tace session, the patient vomited and developed persisting right hypochondralgia.An emergently performed computed tomography (ct) scan of the abdomen revealed acute cholecystitis associated with embolization of peripheral cholecystic artery.Treatment included surgery.The operative notes provided: operation was initiated in a supine position under general anesthesia; ports were placed in a total of 4 sites in the umbilical region, left lower abdomen, and right hypochondriac region: and a laparoscopic cholecystectomy was performed.Laparoscopic observation revealed necrosis of the gallbladder wall and hepatocellular carcinoma (hcc) in the s4 region.The hcc adhered to the omental and duodenum.The cervix of the gallbladder was exposed and the entire circumference of the serosa of the gallbladder was separated, and then the cystic duct and cystic artery were identified.The cystic artery was white in color and not beating.The artery was clipped and dissected, and then the gallbladder was removed.The surgical time was 1 hour and 52 minutes, with little loss of blood.The histopathological findings were: the wall of resected gallbladder was fragile with change in color; in all layers of the gallbladder wall, edema, degenerative necrosis, and lymphocytic infiltration were noted; a number of drug-eluting beads were noted in the arteries of the gallbladder wall; and fibrin formation was noted around the embolic material.The pathological diagnosis was gangrenous cholecystitis.Postoperative clinical course was uneventful.The patient was discharged to home on the eighth hospital day with planned outpatient follow-up.After discharge, two more sessions of tace were performed for hcc on unspecified dates.However, the patient experienced disease progression and hepatic failure and died 6 months after the operation.The physician author assessed the gangrenous cholecystitis as probably related to the use of dc bead and assessed fatal hepatic failure as not related to the use of dc bead.The author did not provide assessment for the events of non-target embolization and off label use of a device to the use of dc beads.The physician also commented, "in this case, acute cholecystitis was considered to be caused by embolization of the cystic artery while dcb was injected into the right hepatic artery branch." the company assessed the events of hepatic failure (fatal), disease progression (fatal), gangrenous cholecystitis ( hospitalization, required intervention) and drug-eluting bead in gallbladder wall arteries/ non-target embolization ( hospitalization, required intervention) as serious.Follow up will be attempted.Follow-up information was received on 18-jan-2017: follow-up information was received from the author via the company distributor.Additional medical history included a child-pugh classification of class b; and a correction in the maximum tumor diameter from 30 mm to 25 mm.Also additional details regarding the tace procedure included the degree of embolization for the disappearance rate of contrast medium was 5 heartbeats after contrast medium injection.There was also a presence of collateral circulation at the arterial branches in the right anterior segment of the liver which were noted to be feeding the hcc tumour in s4 segment.On (b)(6) 2014, the patient experienced gangrenous cholecystitis following a tace procedure using 1 vial of dc beads (100-300 mcm) loaded with 50 mg epirubicin.On (b)(6) 2014, a laparoscopic cholecystectomy was performed.On (b)(6) 2014, the patient was discharged home on the eighth hospital day.On an unspecified date, the patient was recovering from the gangrenous cholecystitis.On (b)(6) 2015, 6 months after the operation due to gangrenous cholecystitis, the patient died from disease progression and hepatic failure.Additional information is expected.Follow-up information was received on 23-jan-2017 from the reporting author: on (b)(6) 2014, the patient's platelet count was 11.0 (10^4/microl).On (b)(6) 2014, the patient's platelet count was 10.8 (10^4/microl).The outcome of the decreased platelet count was not reported.The patient's additional laboratory data has been entered in the dedicated section.On (b)(6) 2014, the patient was recovered from the gangrenous cholecystitis.The reporter did not assess the seriousness or the causality of the event decreased platelet count to dc bead.The company considered the event decreased platelet count as non-serious.Follow-up information will be requested.Case comment: hepatic failure and disease progression are considered unlisted as per dc beads instructions for use, however are expected in patients with liver cancer.Gangrenous cholecystitis and non-target embolization are listed.In agreement with the authors and due to the strong temporal relationship, the company considers the events of gangrenous cholecystitis and device deployment issue are related to treatment with dc beads.In agreement with the authors, the company considers the event of hepatic failure as not related to the dc bead but in absence of the author's assessment, the company considers the event of fatal disease progression as not related to treatment with dc bead.Off label use of device (device loaded with epirubicin) is not considered an adverse event per se but as a special scenario and thus not assessable as an adverse event.This single case report does not modify the risk benefit balance of dc 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.
|
| |
|
Manufacturer Narrative
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|
Dc bead was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.Dc bead with epirubicin is considered off-label use.
|
| |
|
Event Description
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Hepatic failure [hepatic failure]; disease progression [disease progression]; gangrenous cholecystitis [cholecystitis infective]; drug-eluting bead in gallbladder wall arteries/ non-target embolization [device deployment issue]; decreased platelet count [platelet count decreased]; device loaded with epirubicin [off label use of device].Case description: initial information received on 21-dec-2016: this literature case report was published in 2016 in an unspecified journal by kusakabe m, et al with the title "a case of gangrenous cholecystitis after transarterial chemoembolization with drug-eluting beads" regarding a (b)(6) year old male patient.Medical history included liver cirrhosis caused by (b)(6), multiple hepatocellular carcinomas (ct3, n0, m0, stage iii) with the largest tumour of 30 mm at the medial segment (s4), and previous transcatheter arterial chemoembolization (tace) using gelatin sponge for a total of 5 times during the period of 7 months after the initial admission.This kept the patient in a stable condition.In the previous tace procedures, embolization was performed through the medial branch of the left hepatic artery.Other concomitant medications were not provided.The patient received dc beads for his sixth session of tace on an unspecified date.A total of 20 ml of suspension containing 100-300 mcm 1a of dc beads, 50 mg of epirubicin, 2 ml of injection solvent, 9 ml of heparin saline, and 9 ml of iomeron (contrast agent) was prepared and injected intra-arterially.Post-tace angiography revealed and confirmed disappearance of tumor stain in s4.At an unspecified date, immediately after completion of sixth tace session, the patient vomited and developed persisting right hypochondralgia.An emergently performed computed tomography (ct) scan of the abdomen revealed acute cholecystitis associated with embolization of peripheral cholecystic artery.Treatment included surgery.The operative notes provided: operation was initiated in a supine position under general anesthesia; ports were placed in a total of 4 sites in the umbilical region, left lower abdomen, and right hypochondriac region: and a laparoscopic cholecystectomy was performed.Laparoscopic observation revealed necrosis of the gallbladder wall and hepatocellular carcinoma (hcc) in the s4 region.The hcc adhered to the omental and duodenum.The cervix of the gallbladder was exposed and the entire circumference of the serosa of the gallbladder was separated, and then the cystic duct and cystic artery were identified.The cystic artery was white in color and not beating.The artery was clipped and dissected, and then the gallbladder was removed.The surgical time was 1 hour and 52 minutes, with little loss of blood.The histopathological findings were: the wall of resected gallbladder was fragile with change in color; in all layers of the gallbladder wall, edema, degenerative necrosis, and lymphocytic infiltration were noted; a number of drug-eluting beads were noted in the arteries of the gallbladder wall; and fibrin formation was noted around the embolic material.The pathological diagnosis was gangrenous cholecystitis.Postoperative clinical course was uneventful.The patient was discharged to home on the eighth hospital day with planned outpatient follow-up.After discharge, two more sessions of tace were performed for hcc on unspecified dates.However, the patient experienced disease progression and hepatic failure and died 6 months after the operation.The physician author assessed the gangrenous cholecystitis as probably related to the use of dc bead and assessed fatal hepatic failure as not related to the use of dc bead.The author did not provide assessment for the events of non-target embolization and off label use of a device to the use of dc beads.The physician also commented, "in this case, acute cholecystitis was considered to be caused by embolization of the cystic artery while dcb was injected into the right hepatic artery branch." the company assessed the events of hepatic failure (fatal), disease progression (fatal), gangrenous cholecystitis (hospitalization, required intervention) and drug-eluting bead in gallbladder wall arteries/ non-target embolization (hospitalization, required intervention) as serious.Follow up will be attempted.Follow-up information was received on 18-jan-2017: follow-up information was received from the author via the company distributor.Additional medical history included a child-pugh classification of class b; and a correction in the maximum tumor diameter from 30mm to 25mm.Also additional details regarding the tace procedure included the degree of embolization for the disappearance rate of contrast medium was 5 heartbeats after contrast medium injection.There was also a presence of collateral circulation at the arterial branches in the right anterior segment of the liver which were noted to be feeding the hcc tumour in s4 segment.On 19-aug-2014, the patient experienced gangrenous cholecystitis following a tace procedure using 1 vial of dc beads (100-300 mcm) loaded with 50 mg epirubicin.On 20-aug-2014, a laparoscopic cholecystectomy was performed.On 28-aug-2014, the patient was discharged home on the eighth hospital day.On an unspecified date, the patient was recovering from the gangrenous cholecystitis.On 18-feb-2015, 6 months after the operation due to gangrenous cholecystitis, the patient died from disease progression and hepatic failure.Additional information is expected.Follow-up information was received on 23-jan-2017 from the reporting author: on 18-aug-2014, the patient's platelet count was 11.0 (10^4/microl).On 20-aug-2014, the patient's platelet count was 10.8 (10^4/microl).The outcome of the decreased platelet count was not reported.The patient's additional laboratory data has been entered in the dedicated section.On 28-aug-2014, the patient was recovered from the gangrenous cholecystitis.The reporter did not assess the seriousness or the causality of the event decreased platelet count to dc bead.The company considered the event decreased platelet count as non-serious.Follow-up information will be requested.Final assessment on 15-mar-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 these adverse events.It has been assessed that no corrective action is necessary at this time and the report is considered final.Case comment: hepatic failure, disease progression and platelet count decreased are considered unlisted as per dc beads instructions for use, however hepatic failure and disease progression are expected in patients with liver cancer.Gangrenous cholecystitis and non-target embolization are listed.In agreement with the authors and due to the strong temporal relationship, the company considers the events of gangrenous cholecystitis and device deployment issue are related to treatment with dc beads.In agreement with the authors, the company considers the event of hepatic failure as not related to the dc bead but in absence of the author's assessment, the company considers the event of fatal disease progression as not related to treatment with dc bead.In absence of the author's assessment, the company considers the event platelet count decreased not related to dc bead but more likely to be related to the condition of the patient.Off label use of device (device loaded with epirubicin) is not considered an adverse event per se but as a special scenario and thus not assessable as an adverse event.This single case report does not modify the risk benefit balance of dc 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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