| Model Number 100-300 MICROM |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Test Result (2695); Insufficient Information (4580)
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| Event Date 08/04/2014 |
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Event Type
Death
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Event Description
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Initial and follow-up information was received from a user facility, via a partner organization, on the (b)(6) 2014, respectively.It was reported that on (b)(6) 2014, transcatheter arterial chemoembolization (tace) was performed on a patient with hepatocellular carcinoma in the liver (s8 to s4).The patient received 3ml/20ml of ten-fold dilution of device dc bead (bead size: 100-300 um) loaded with epirubicin 50 mg.The mixture of the dc bead and epirubicin 2 ml was injected into the second branch of the left hepatic artery.Patient ast, alt, t-bil and alb levels improved within a week after the tace procedure - patient was discharged.Follow this, patient t-bil went up to 7.4 mg/dl and patient was hospitalized, "due to poor prognosis and prolongation." it is further reported that between (b)(6) 2014, patient bilirubin levels increased from 3.3 u/l to 10 u/l.Report also states that tace was performed a total of 15 times on patient (with bilirubin levels increasing, but then returning to normal levels within a week or so) and a smooth recovery was made each time.Final patient outcome is not reported.
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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.Dc bead is not indicated for use with epirubicin.The equivalent product, lc bead, is available in the usa and is indicated for the treatment of hypervascular tumours and avms.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.Medical assessment: per reported information, the patient suffered elevated bilirubin after tace procedure.Further information is needed, but this could represent liver failure.The follow-up information received on (b)(6) 2014 stated: the patient's ast, alt, t-bil, and alb improved over the week post tace, and patient was discharged from the hospital.However, during recovery improvement slowed and t-bil went up to 7.4 mg/dl, so the patient was transferred to another hospital due to poor prognosis.Due to the patient being transferred to another hospital this report is conservatively assessed as serious and reportable.
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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.Dc bead is not indicated for use with epirubicin.The equivalent product, lc bead, is available in the usa and is indicated for the treatment of hypervascular tumours and avms.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.Prior to receipt of new information, the complaint in question had been closed by the manufacturer based on a medical review and internal investigation.This concluded that the most probable root cause of the issue was not a btg product deficiency/malfunction but more likely due to elevated bilirubin which is an expected complication of the procedure and an expected event with the use of epirubicin.The additional information received by the manufacturer will result in the complaint being re-opened for an assessment of the impact, if any, on current complaint investigation.
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Event Description
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On (b)(6) 2014, transcatheter arterial chemoembolization (tace) was performed on a patient with hepatocellular carcinoma.The patient received dc bead (bead size 100-300um) loaded with epirubicin 50 mg.The mixture was injected into the second branch of the left hepatic artery.Patient t-bil went up to 7 4 mg/dl, and patient was hospitalised, "due to poor prognosis and prolongation".Later the patient's bilirubin levels increased from 3.5 u/l to 10.8 u/l.Tace was performed a total of 15 times on the patient (with bilirubin levels increasing, but then returning to normal levels within a week or so) and a smooth recovery was made each time.Additional information was received from a user facility, via a partner organization, on the (b)(6) 2014.It was reported that the patient experienced the liver disorder on (b)(6) 2014.
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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.Dc bead is not indicated for use with epirubicin.The equivalent product, lc bead, is available in the usa and is indicated for the treatment of hypervascular tumours and avms.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.Medical assessment: per reported information, the patient suffered elevated bilirubin after tace procedure.Further information is needed, but this could represent liver failure.The follow-up information received on 23rd june 2014 stated the patient's ast, alt, t-bil and alb improved over the week post tace, and patient was discharged from the hospital.However during recovery improvement slowed and t-bil went up to 7.4 mg/dl, so the patient was transferred to another hospital due to poor prognosis.Due to the patient being transferred to another hospital this report is conservatively assessed as serious and reportable.Complaint # (b)(4).Prior to receipt of new information, the complaint in question had been closed by the manufacturer based on a medical review and internal investigation.This concluded that the most probable root cause of the issue was not a btg product deficiency/malfunction but more likely due to elevated bilirubin which is an expected complication of the procedure and an expected event with the use of epirubicin.The additional information received by the manufacturer will result in the complaint being re-opened for an assessment of the impact, if any, on current complaint investigation.Submission of this report does not constitute an admission by biocompatibles uk ltd that the product caused or contributed to an adverse effect.A review of the investigation performed under customer complaint investigation summary report (b)(4) determined that the conclusions were valid: the potential root cause for the patients changing health condition following the use of tace was due to fluctuating ast, alt, t-bilirubin and albumin levels which is an expected complication of the procedure and an expected event with the use of epirubicin.No corrective and preventative actions (capa) plan was identified as a result of the investigation.A risk review for this complaint concluded that no device failure, trend in a type of incident or unexpected risk to patient or users health has been identified.Raised liver enzymes and bilirubin post tace are an expected and transient effect of the procedure.No field safety corrective action or product recall is required.
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Event Description
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Hepatic failure [hepatic failure] fatal.Hepatic infarction.Right hepatic duct stenosis [bile duct stenosis] liver disorder.Bilirubin was 3.3 u/l.[blood bilirubin increased].Ast and alt increased [aspartate aminotransferase increased].Ast and alt increased [alanine aminotransferase increased].Off-label use.Case description: initial and follow-up information was received from a user facility, via a partner organization, on the 09th and 23rd of june 2014, respectively.It was reported that on (b)(6) 2014, transcatheter arterial chemoembolization (tace) was performed on a patient with hepatocellular carcinoma in the liver (s8 to s4).The patient received 3 ml/20 ml of ten-fold dilution of device dc bead (bead size: 100-300 microm) loaded with epirubicin 50 mg.The mixture of dc bead and epirubicin 2 ml was injected into the second branch of the left hepatic artery.Patient ast, alt, t-bil and alb levels improved within a week after the tace procedure- patient was discharged.Following this, patient t-bil went up to 7.4 mg/dl and patient was hospitalised, "due to poor prognosis and prolongation".It is further reported that between (b)(6) to (b)(6) 2014, patient bilirubin levels increased from 3.3 u/l to 10 u/l.Report also states that tace was performed a total of 15 times on patient (with bilirubin levels increasing, but then returning to normal levels within a week or so) and a smooth recovery was made each time.Final patient outcome is not reported.Additional information was received from a user facility, via a partner organization, on the 08th of august 2014.It was reported that the patient experienced the liver disorder on (b)(6) 2014.Follow-up information received on 20-feb-2015: it was reported that total bilirubin was 3.3 mg/dl on (b)(6) 2014 (data from other hospital) and 6.5 mg/dl on (b)(6) 2014 (measured in an outpatient setting).On (b)(6) 2014, magnetic resonance cholangiopancreatography (mrcp) revealed right hepatic duct stenosis.On (b)(6) 2014, endoscopic retrograde cholangiopancreatography (ercp), followed by endoscopic sphincterotomy (est) was performed and biliary stenting was attempted, which was unsuccessful.On (b)(6) 2014, percutaneous transhepatic biliary drainage (ptbd) tube was attempted to insert through the left hepatic duct for several times.But, hepatic infarction was evident with 2.8mm of bile duct dilatation and endoscopic cholangiography was unsuccessful.Total bilirubin level continued to increase, and on (b)(6) 2014, the patient has passed away due to hepatic failure.Tace has been performed 14 times within 8 years before using dc bead for the hcc relapse following hepatectomy.Stenosis in the hepatic artery branch was evident due to prior tace.Bile duct injuries following tace were not observed.At this time, liver disorder developed within several days following tace using dc bead.The causal relationship was unknown, however, it was considered that the event was related to dc.As from reporter, another causal factors besides dc bead could be the patient's underlying disease (type c hepatic cirrhosis).The reporter assessed the events (hepatic failure, hepatic infarction, liver disorder, bile duct stenosis, blood bilirubin increased, aspartate aminotransferase increased and alanine aminotransferase increased ) as probably related to dc bead-tace procedure.Case comment: this case documents an off-label use of dc bead since deb-tace was performed using dc bead loaded with epirubicin, whereas dc bead is indicated only for use with doxorubicin and irinotecan.The serious events liver disorder, hepatic failure, hepatic infarction, and the non-serious events liver disorder, bile duct stenosis, blood bilirubin increased, aspartate aminotransferase increased and alanine aminotransferase increased are unlisted according to the current instruction for use of dc bead.The physician considered the events as probably related to dc-bead therapy although the patient's underlying disease (type c hepatic cirrhosis) could have also contributed to the event.The company considered also the events experienced by the patient as related to the product, as its 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 uk were in 2004.Sales data from jan-2010 for dc bead is: eu 116.815 vials and row 59.919 vials.
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