MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD LC BEAD; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE

Model Number 100-300 MICROMETER

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Abdominal Pain (1685); Encephalopathy (1833); Hemorrhage/Bleeding (1888); Hepatitis (1897); Ascites (2596)

Event Type  No Answer Provided  

Event Description

Mrecist was pd (progressive disease) [disease progression]; abdominal pain [abdominal pain]; severe ascites [ascites]; encephalopathy [encephalopathy]; gi bleeding [gastrointestinal haemorrhage]; loaded with 50 mg of doxorubicin [off label use of device].Case description: initial information received on (b)(6) 2016: this literature case report was published in 2015 in the journal of vascular and interventional radiology by deipolyi ar et al.With the title "safety and efficacy of 70-150 microm and 100-300 microm drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma" and concerning three patients.The patients' medical history included hepatocellular carcinoma.No information concerning concomitant medication was provided.Between dec-2011 and dec 2012, the patients in group i received two vials of 100-300 micron lc bead m1 loaded with 50 mg of doxorubicin as transarterial chemoembolization for unresectable hepatocellular carcinoma (hcc).The patients received this dosing into the right vessels.On an unspecified date, a (b)(6) male patient with a history of non-alcoholic steatohepatitis (nash) experienced gi bleeding.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 37 mm.The patient's child-pugh score was a.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with a relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 1.5 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 21 mm.The patient's child-pugh score was a.The outcome of the event is unknown.On an unspecified date, a (b)(6) male patient with a relevant history of alcohol abuse (etoh) experienced encephalopathy.The patient's total bilirubin was 2.4 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 40 mm.The patient's child-pugh score was a.The outcome of the event are unknown.The authors assessed the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as related to the use of lc bead m1.The authors did not provide an assessment for the event of disease progression.The company assessed the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as serious (medically significant) and the issue of off-label use as non-assessable.The case is linked to case (b)(4) from the same literature article.Case comment: gastrointestinal hemorrhage is considered listed as per lc bead m1 instructions for use whereas disease progression, abdominal pain, ascites, encephalopathy and off-label use of a device are unlisted.In agreement with the authors, the company considered the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as related to the product since this possibility cannot be excluded.In absence of the author's assessment, the company considers disease progression as related to the product since this possibility cannot be excluded.Off-label use of device was considered non-assessable as an event.This single case report does not modify the risk benefit balance of lc bead m1.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Event Description

Mrecist was pd (progressive disease) [disease progression]; abdominal pain [abdominal pain]; severe ascites [ascites]; encephalopathy [encephalopathy]; gi bleeding [gastrointestinal haemorrhage]; loaded with 50 mg of doxorubicin [off label use of device].Case description: initial information received on (b)(6) 2016: this literature case report was published in 2015 in the journal of vascular and interventional radiology by (b)(4).With the title "safety and efficacy of 70-150 microm and 100-300 microm drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma" and concerning three patients.The patients' medical history included hepatocellular carcinoma.No information concerning concomitant medication was provided.Between dec-2011 and dec-2012, the patients in group i received two vials of 100-300 micron lc bead m1 loaded with 50 mg of doxorubicin as transarterial chemoembolization for unresectable hepatocellular carcinoma (hcc).The patients received this dosing into the right vessels.On an unspecified date, a (b)(6) male patient with a history of non-alcoholic steatohepatitis (nash) experienced gi bleeding.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 37 mm.The patient's child-pugh score was a.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with a relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 1.5 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 21 mm.The patient's child-pugh score was a.The outcome of the event is unknown.On an unspecified date, a (b)(6) male patient with a relevant history of alcohol abuse (etoh) experienced encephalopathy.The patient's total bilirubin was 2.4 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 40 mm.The patient's child-pugh score was a.The outcome of the event are unknown.The authors assessed the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as related to the use of lc bead m1.The authors did not provide an assessment for the event of disease progression.The company assessed the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as serious (medically significant) and the issue of off-label use as non-assessable.The case is linked to case (b)(4) from the same literature article.Follow-up information received on 21-jun-2016: follow-up information has been sought.As of 21-jun-2016, no additional information has been received.Case comment: gastrointestinal hemorrhage is considered listed as per lc bead m1 instructions for use whereas disease progression, abdominal pain, ascites, encephalopathy and off-label use of a device are unlisted.In agreement with the authors, the company considered the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as related to the product since this possibility cannot be excluded.In absence of the author's assessment, the company considers disease progression as related to the product since this possibility cannot be excluded.Off-label use of device was considered non-assessable as an event.This single case report does not modify the risk benefit balance of lc bead m1.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Event Description

Mrecist was pd (progressive disease) [disease progression], abdominal pain [abdominal pain], severe ascites [ascites], encephalopathy [encephalopathy], gi bleeding [gastrointestinal haemorrhage], loaded with 50 mg of doxorubicin [off label use of device].Case description: initial information received on 18-may-2016: this literature case report was published in 2015 in the journal of vascular and interventional radiology by deipolyi ar et al.With the title "safety and efficacy of 70-150 microm and 100-300 microm drug-eluting bead transarterial chemoembolization for hepatocellular carcinoma" and concerning three patients.The patients' medical history included hepatocellular carcinoma.No information concerning concomitant medication was provided.Between dec-2011 and dec2012, the patients in group i received two vials of 100-300 micron lc bead m1 loaded with 50 mg of doxorubicin as transarterial chemoembolization for unresectable hepatocellular carcinoma (hcc).The patients received this dosing into the right vessels.On an unspecified date, a (b)(6) male patient with a history of non-alcoholic steatohepatitis (nash) experienced gi bleeding.The patient's total bilirubin was 0.6 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 37 mm.The patient's child-pugh score was a.Following treatment with lc bead m1, the mrecist evaluation revealed progressive disease (pd).The outcomes of the events are unknown.On an unspecified date, a (b)(6) male patient with a relevant medical history of (b)(6) experienced severe ascites/abdominal pain.The patient's total bilirubin was 1.5 mg/dl approximately 2 days prior to the procedure.The index lesion was measured as 21 mm.The patient's child-pugh score was a.The outcome of the event is unknown.On an unspecified date, a (b)(6) male patient with a relevant history of alcohol abuse (etoh) experienced encephalopathy.The patient's total bilirubin was 2.4 mg/dl approximately 2 days prior to the procedure.His index lesion was measured as 40 mm.The patient's child-pugh score was a.The outcome of the event are unknown.The authors assessed the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as related to the use of lc bead m1.The authors did not provide an assessment for the event of disease progression.The company assessed the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as serious (medically significant) and the issue of off-label use as non-assessable.The case is linked to case (b)(4) from the same literature article.Follow-up information received on 21-jun-2016: follow-up information has been sought.As of 21-jun-2016, no additional information has been received.Follow-up information received on 22-jul-2016: follow-up information was requested to further investigate the event but no new information has been received.No device failure has been identified as a result of this adverse event.It has been assessed that no corrective action is necessary at this time.The report is final.Case comment: gastrointestinal hemorrhage is considered listed as per lc bead m1 instructions for use whereas disease progression, abdominal pain, ascites, encephalopathy and off-label use of a device are unlisted.In agreement with the authors, the company considered the events of gastrointestinal hemorrhage, disease progression, abdominal pain, ascites, and encephalopathy as related to the product since this possibility cannot be excluded.In absence of the author's assessment, the company considers disease progression as related to the product since this possibility cannot be excluded.Off-label use of device was considered non-assessable as an event.This single case report does not modify the risk benefit balance of lc bead m1.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

• Brand Name: LC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 4125273273
• MDR Report Key: 5684665
• MDR Text Key: 46168499
• Report Number: 3002124545-2016-00038
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 MICROMETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other