| Model Number 100-300 MICROM |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
High Blood Pressure/ Hypertension (1908); Ascites (2596); Cancer (3262)
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| Event Date 06/29/2015 |
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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 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 hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Ruptured hepatic carcinoma [liver carcinoma ruptured].Peritoneal dissemination [metastases to peritoneum].Ascites [ascites].Case description: initial information received on 11-sep-2015: this spontaneous medical device report was received from a physician via the company distributor, concerning a (b)(6) male patient.No concomitant diseases, no concomitant drugs and no other medical history were reported.On (b)(6) 2015, the patient underwent tace using dc bead (lot number, expiration date, size and dosage not reported) for an unknown indication.On (b)(6) 2015, a ct scan revealed hemorrhage around the liver and a diagnosis of ruptured hepatic carcinoma was made.No clinical symptom such as anemia was observed.The patient's hospitalization was prolonged beyond the original plan and a follow-up of his clinical course was performed.On (b)(6) 2015, the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again for an additional tace treatment using embosphere (trisacryl gelatin microspheres) for treatment of hepatic carcinoma.On (b)(6) 2015, a ct scan revealed non-serious peritoneal dissemination.Nexavar (sorafenib tosilate) was administered and the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again due to identified ascites, and on (b)(6) 2015 he is being hospitalized: the ruptured hepatic carcinoma and the peritoneal dissemination had not recovered.Ruptured hepatic carcinoma and peritoneal dissemination were considered by the reporter as possibly related to dc-bead therapy.The event ascites was not assessed by the reporter.The company considers the events ruptured hepatic carcinoma, peritoneal dissemination and ascites serious, since they required multiple hospitalizations.Additional information received on 18-sep-2015: on (b)(6) 2015, the patient underwent tace for primary hepatocellular carcinoma (hcc) with one vial of dc bead (100-300 microm) (batch number not reported, expiration date: 29-jun-2015) loaded with epirubicin 75mg.Patient's medical history included prostatic hypertrophy.Patient's concomitant disease was hypertension.On (b)(6) 2015, patient's ruptured hepatic carcinoma had recovered.A follow-up by observation was only performed without embolization.The patient did not present any symptoms of hepatic rupture.No treatment was provided.On (b)(6) 2015, peritoneal dissemination had not recovered.The patient remained hospitalized.The patient did not suffer from hepatic cirrhosis, his child-pugh classification was class a, 5 points.Thrombosis was not present.The possible cause of ruptured hcc could be tumor size (maximum diameter 30 mm), rise from surface of the liver; the concomitant disease of hypertension.No extrahepatic infiltration was present.On (b)(6) 2015 before tace, vascular lake was not observed.During tace on (b)(6) 2015, it was observed.No treatment was administered to the patient.Pre-tace findings were provided: number of tumors: 1; maximum tumor diameter: 30 mm; number of tace performed to date: 3 times including current one (once with the product); number of rea to date: 0.Tace-related parameters were provided: degree of embolization was about 5 heartbeats (for the disappearance rate of contrast medium, 5 heartbeats after contrast medium injection were used as a reference); the embolization site and range was s6 (periphery).Complete lab data were provided (results of (b)(6)).The physician considered the ruptured hepatic carcinoma and peritoneal dissemination as possibly related to dc bead-tace.He assessed that as the peritoneal dissemination occurred after the ruptured hepatocellular cancer, the causal relationship with dc bead cannot be rules out.The event ascites was not considered as an adverse event by the reporter.Case comment: the events liver carcinoma rupture, metastases to the peritoneum and ascites are considered unlisted according to dc bead current instructions for use.Dc bead loaded with epirubicin hydrochloride is considered off-label use according to dc bead current instructions for use.The physician considered the event liver carcinoma rupture and metastases to the peritoneum as possibly related to the use of dc bead.The event ascites was not assessed by the reporter.Although the underlying liver disease of the patient as well as the concomitant disease hypertension could have contributed to the events, the company considered also the events experienced by the patient as related to the product, as dc bead role cannot be excluded.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.The first sales for dc bead in the (b)(6) were in 2004.Sales data from jan-2010 for dc bead is: (b)(4) vials and (b)(4) vials.The follow-up information received on 18-sep-2015 did not change the assessment of the case.
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Manufacturer Narrative
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Dc bead with epirubicin 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 hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Ruptured hepatic carcinoma [liver carcinoma ruptured]
peritoneal dissemination [metastases to peritoneum]
ascites [ascites]
case description:
initial information received on 11-sep-2015:
this spontaneous medical device report was received from a physician via the company distributor, concerning a (b)(6) male patient.No concomitant diseases, no concomitant drugs and no other medical history were reported.On (b)(6) 2015, the patient uderwent tace using dc bead (lot number, expiration date, size and dosage not reported) for an unknown indication.On (b)(6) 2015, a ct scan revealed hemorrhage around the liver and a diagnosis of ruptured hepatic carcinoma was made.No clinical symptom such as anemia was observed.The patient's hospitalization was prolonged beyond the original plan and a follow-up of his clinical course was performed.On (b)(6) 2015, the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again for an additional tace treatment using embosphere (trisacryl gelatin microspheres) for treatment of hepatic carcinoma.On (b)(6) 2015, a ct scan revealed non-serious peritoneal dissemination.Nexavar (sorafenib tosilate) was administered and the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again due to identified ascites, and on (b)(6) 2015 he is being hospitalized: the ruptured hepatic carcinoma and the peritoneal dissemination had not recovered.Ruptured hepatic carcinoma and peritoneal dissemination were considered by the reporter as possibly related to dc-bead therapy.The event ascites was not assessed by the reporter.The company considers the events ruptured hepatic carcinoma, peritoneal dissemination and ascites serious, since they required multiple hospitalizations.Additional information received on 18-sep-2015:
on (b)(6) 2015, the patient underwent tace for primary hepatocallular carcinoma (hcc) with one vial of dc bead (100-300 microm) (batch number not reported, expiration date: 29-jun-2015) loaded with epirubuicin 75mg.Patient's medical history included prostatic hypertrophy.Patient's concomitant disease was hypertension.On (b)(6) 2015, patient's ruptured hepatic carcinoma had recovered.A follow-up by observation was only performed without embolization.The patient did not present any symptoms of hepatic rupture.No treatment was provided.On 18-sep-2015, peritoneal dissemination had not recovered.The patient remained hospitalized.The patient did not suffer from hepatic cirrhosis, his child-pugh classification was class a, 5 points.Thrombosis was not present.The possible cause of ruptured hcc could be tumor size (maximum diameter 30 mm), rise from surface of the liver; the concomitant disease of hypertension.No extrahepatic infiltration was present.On (b)(6) 2015 before tace, vascular lake was not observed.During tace on (b)(6) 2015, it was observed.No treatment was administered to the patient.Pre-tace findings were provided: number of tumors: 1; maximum tumor diameter: 30 mm; number of tace performed to date: 3 times including current one (once with the product); number of rea to date: 0.Tace-related parameters were provided: degree of embolization was about 5 heartbeats (for the disappearance rate of contrast medium, 5 heartbeats after contrast medium injection were used as a reference); the embolization site and range was s6 (periphery).Complete lab data were provided (results of (b)(6) 2015).The physician considered the ruptured hepatic carcinoma and peritoneal dissemination as possibly related to dc bead-tace.He assessed that as the peritoneal dissemination occurred after the ruptured hepatocellular cancer, the causal relationship with dc bead cannot be rules out.The event ascites was not considered as an adverse event by the reporter.Case comment:
the events liver carcinoma rupture, metastases to the peritoneum and ascites are considered unlisted according to dc bead current instructions for use.Dc bead loaded with epirubicin hydrochloride is considered off-label use according to dc bead current instructions for use.The physician considered the event liver carcinoma rupture and metastases to the peritoneum as possibly related to the use of dc bead.The event ascites was not assessed by the reporter.Although the underlying liver disease of the patient as well as the concomitant disease hypertension could have contributed to the events, the company considered also the events experienced by the patient as related to the product, as dc bead role cannot be excluded.This single case report does not modify the risk benefit balance of dc bead.The company is continously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.(b)(4).The follow-up information received on 18-sep-2015 did not change the assessment of the case.
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Manufacturer Narrative
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Dc bead with epirubicin 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 hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Ruptured hepatic carcinoma [liver carcinoma ruptured].Peritoneal dissemination [metastases to peritoneum].Cancerous peritonitis [malignant ascites].Ascites [ascites].Dc bead loaded with epirubicin 75mg [off label use].Case description: initial information received on 11-sep-2015: this spontaneous medical device report was received from a physician via the company distributor, concerning a n(b)(4)-year-old male patient.No concomitant diseases, no concomitant drugs and no other medical history were reported.On (b)(6) 2015, the patient uderwent tace using dc bead (lot number, expiration date, size and dosage not reported) for an unknown indication.On (b)(6) 2015, a ct scan revealed hemorrhage around the liver and a diagnosis of ruptured hepatic carcinoma was made.No clinical symptom such as anemia was observed.The patient's hospitalization was prolonged beyond the original plan and a follow-up of his clinical course was performed.On (b)(6) 2015, the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again for an additional tace treatment using embosphere (trisacryl gelatin microspheres) for treatment of hepatic carcinoma.On (b)(6) 2015, a ct scan revealed non-serious peritoneal dissemination.Nexavar (sorafenib tosilate) was administered and the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again due to identified ascites, and on (b)(6) 2015 he is being hospitalized: the ruptured hepatic carcinoma and the peritoneal dissemination had not recovered.Ruptured hepatic carcinoma and peritoneal dissemination were considered by the reporter as possibly related to dc-bead therapy.The event ascites was not assessed by the reporter.The company considers the events ruptured hepatic carcinoma, peritoneal dissemination and ascites serious, since they required multiple hospitalizations.Additional information received on 18-sep-2015: on (b)(6) 2015, the patient underwent tace for primary hepatocellular carcinoma (hcc) with one vial of dc bead (100-300 microm) (batch number not reported, expiration date: 29-jun-2015) loaded with epirubuicin 75mg.Patient's medical history included prostatic hypertrophy.Patient's concomitant disease was hypertension.On (b)(6) 2015, patient's ruptured hepatic carcinoma had recovered.A follow-up by observation was only performed without embolization.The patient did not present any symptoms of hepatic rupture.No treatment was provided.On (b)(6) 2015, peritoneal dissemination had not recovered.The patient remained hospitalized.The patient did not suffer from hepatic cirrhosis, his child-pugh classification was class a, 5 points.Thrombosis was not present.The possible cause of ruptured hcc could be tumor size (maximum diameter 30 mm), rise from surface of the liver; the concomitant disease of hypertension.No extrahepatic infiltration was present.On (b)(6 )2015 before tace, vascular lake was not observed.During tace on (b)(6) 2015, it was observed.No treatment was administered to the patient.Pre-tace findings were provided: number of tumors: 1; maximum tumor diameter: 30 mm; number of tace performed to date: 3 times including current one (once with the product); number of rea to date: 0.Tace-related parameters were provided: degree of embolization was about 5 heartbeats (for the disappearance rate of contrast medium, 5 heartbeats after contrast medium injection were used as a reference); the embolization site and range was s6 (periphery).Complete lab data were provided (results of (b)(6) 2015).The physician considered the ruptured hepatic carcinoma and peritoneal dissemination as possibly related to dc bead-tace.He assessed that as the peritoneal dissemination occurred after the ruptured hepatocellular cancer, the causal relationship with dc bead cannot be rules out.The event ascites was not considered as an adverse event by the reporter.Additional information received on 11-dec-2015: prior to tace of (b)(6) 2015 there was no haemorrhage around the liver.The ct scan of (b)(6) 2015 and the examinations performed before and after the tace of (b)(6) 2015 did not show any peritoneal dissemination.On (b)(6) 2015 a ct scan revealed peritoneal dissemination.No cytologic examination was performed during the re-hospitalization.On (b)(6) 2015 the patient developed cancerous peritonitis and massive bloody ascites.He underwent a drainage of the abdominal fluid.Patient's general conditions gradually aggravated, and he passed away on an unspecified date.The reporting physician did not assess the causality between dc bead and the cancerous peritonitis.Case comment: the events liver carcinoma rupture, metastases to the peritoneum, malignant ascites and ascites are considered unlisted according to dc bead current instructions for use.Dc bead loaded with epirubicin hydrochloride is considered off-label use according to dc bead current instructions for use.The physician considered the event liver carcinoma rupture and metastases to the peritoneum as possibly related to the use of dc bead.The events malignant ascites and ascites was not assessed by the reporter.Although the underlying liver disease of the patient as well as the concomitant disease hypertension could have contributed to the events, the company considered also the events experienced by the patient as related to the product, as dc bead role cannot be excluded.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.(b)(4).
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Manufacturer Narrative
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Dc bead with epirubicin 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 hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Ruptured hepatic carcinoma [liver carcinoma ruptured]; peritoneal dissemination [metastases to peritoneum]; cancerous peritonitis [malignant ascites]; ascites [ascites]; dc bead loaded with epirubicin 75mg [off label use].Case description: initial information received on 11-sep-2015: this spontaneous medical device report was received from a physician via the company distributor, concerning a (b)(6) male patient.No concomitant diseases, no concomitant drugs and no other medical history were reported.On (b)(6) 2015, the patient underwent tace using dc bead (lot number, expiration date, size and dosage not reported) for an unknown indication.On (b)(6) 2015, a ct scan revealed hemorrhage around the liver and a diagnosis of ruptured hepatic carcinoma was made.No clinical symptom such as anemia was observed.The patient's hospitalization was prolonged beyond the original plan and a follow-up of his clinical course was performed.On (b)(6) 2015, the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again for an additional tace treatment using embosphere (trisacryl gelatin microspheres) for treatment of hepatic carcinoma.On (b)(6) 2015, a ct scan revealed non-serious peritoneal dissemination.Nexavar (sorafenib tosilate) was administered and the patient was temporarily discharged.On (b)(6) 2015, the patient was hospitalized again due to identified ascites, and on (b)(6) 2015 he is being hospitalized: the ruptured hepatic carcinoma and the peritoneal dissemination had not recovered.Ruptured hepatic carcinoma and peritoneal dissemination were considered by the reporter as possibly related to dc-bead therapy.The event ascites was not assessed by the reporter.The company considers the events ruptured hepatic carcinoma, peritoneal dissemination and ascites serious, since they required multiple hospitalizations.Additional information received on 18-sep-2015: on (b)(6) 2015, the patient underwent tace for primary hepatocallular carcinoma (hcc) with one vial of dc bead (100-300 microm) (batch number not reported, expiration date: 29-jun-2015) loaded with epirubuicin 75mg.Patient's medical history included prostatic hypertrophy.Patient's concomitant disease was hypertension.On (b)(6) 2015, patient's ruptured hepatic carcinoma had recovered.A follow-up by observation was only performed without embolization.The patient did not present any symptoms of hepatic rupture.No treatment was provided.On (b)(6) 2015, peritoneal dissemination had not recovered.The patient remained hospitalized.The patient did not suffer from hepatic cirrhosis, his child-pugh classification was class a, 5 points.Thrombosis was not present.The possible cause of ruptured hcc could be tumor size (maximum diameter 30 mm), rise from surface of the liver; the concomitant disease of hypertension.No extrahepatic infiltration was present.On (b)(6) 2015 before tace, vascular lake was not observed.During tace on (b)(6) 2015, it was observed.No treatment was administered to the patient.Pre-tace findings were provided: number of tumors: 1; maximum tumor diameter: 30 mm; number of tace performed to date: 3 times including current one (once with the product); number of rea to date: 0.Tace-related parameters were provided: degree of embolization was about 5 heartbeats (for the disappearance rate of contrast medium, 5 heartbeats after contrast medium injection were used as a reference); the embolization site and range was s6 (periphery).Complete lab data were provided (results of (b)(6) 2015).The physician considered the ruptured hepatic carcinoma and peritoneal dissemination as possibly related to dc bead-tace.He assessed that as the peritoneal dissemination occurred after the ruptured hepatocellular cancer, the causal relationship with dc bead cannot be rules out.The event ascites was not considered as an adverse event by the reporter.Additional information received on 11-dec-2015: prior to tace of (b)(6) 2015 there was no haemorrhage around the liver.The ct scan of (b)(6) 2015 and the examinations performed before and after the tace of (b)(6) 2015 did not show any peritoneal dissemination.On (b)(6) 2015 a ct scan revealed peritoneal dissemination.No cytologic examination was performed during the re-hospitalization.On (b)(6) 2015 the patient developed cancerous peritonitis and massive bloody ascites.He underwent a drainage of the abdominal fluid.Patient's general conditions gradually aggravated, and he passed away on an unspecified date.The reporting physician did not assess the causality between dc bead and the cancerous peritonitis.Final assessment on (b)(6) 2016: no device failure has been identified as a result of this adverse event.Follow up information was requested to further investigate the event, additional information received was processed within the medwatch.No further informationis expected.It has been assessed that no corrective action is necessary at this time and the report is final.Case comment: the events liver carcinoma rupture, metastases to the peritoneum, malignant ascites and ascites are considered unlisted according to dc bead current instructions for use.Dc bead loaded with epirubicin hydrochloride is considered off-label use according to dc bead current instructions for use.The physician considered the event liver carcinoma rupture and metastases to the peritoneum as possibly related to the use of dc bead.The events malignant ascites and ascites was not assessed by the reporter.Although the underlying liver disease of the patient as well as the concomitant disease hypertension could have contributed to the events, the company considered also the events experienced by the patient as related to the product, as dc bead role cannot be excluded.This single case report does not modify the risk benefit balance of dc bead.The company is continously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.The first sales for dc bead in the (b)(6) were in 2004.Sales data from (b)(4) 2010 for dc bead is: (b)(4) 116.815 vials and row 59.919 vials.
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