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

Model Number 300-500 MICROM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Event Description

Intrahepatic biliary dilatation [biliary dilatation].Severe right upper quadrant pain [abdominal pain upper].Preloaded with doxorubicin [off label use of device].Case description: initial information received on 18-may-2016: this literature case report was published in 2011 in cardiovascular and interventional radiology by gaur sk et al.With the title "hepatic arterial chemoembolization using drug-eluting beads in gastrointestinal neuroendocrine tumor metastatic to the liver" and concerned a (b)(6) female patient who experienced severe right upper quadrant pain and intrahepatic biliary dilatation.The patient's medical history included a previous left hepatectomy.No information concerning concomitant medication was provided.On an unspecified date between jun-2004 and jun-2009, the patient received lc bead (300-500 microm) loaded with 100 mg of doxorubicin and contour se particles (500-700 microm) as right lobe drug-eluting bead chemoembolization for metastatic gi neuroendocrine tumor to the liver.On an unspecified date after the drug-eluting bead chemoembolization, the patient presented to the emergency department with severe right upper quadrant pain.An enhanced-ct of the abdomen showed a wedge-shaped perfusion abnormality in the posterior segment of the right lobe, in addition to intrahepatic biliary dilatation.The patient was treated with percutaneous transhepatic cholangiography and internal/external biliary stent placement.The patient subsequently did well and the biliary tube was removed without complication.During follow-up, 501 days after chemoembolization, the patient's disease was classified as an objective response which is defined as a partial or complete tumor response.The events of severe right upper quadrant pain and intrahepatic biliary dilatation are resolved.The authors assessed the event of severe right upper quadrant pain and intrahepatic biliary dilatation as related to the use of lc bead.The company assessed the events of severe right upper quadrant pain and intrahepatic biliary dilatation as serious (hospitalization, intervention required) and the issue of off-label use as non-assessable.The case is linked to (b)(4).Case comment: abdominal pain upper, biliary dilatation and off label use are considered unlisted as per lc bead instructions for use.In agreement with the authors, the company considered the events of abdominal pain upper and biliary dilatation as related to the device 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.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

Intrahepatic biliary dilatation [biliary dilatation].Severe right upper quadrant pain [abdominal pain upper].Preloaded with doxorubicin [off label use of device].Case description: initial information received on 18-may-2016: this literature case report was published in 2011 in cardiovascular and interventional radiology by gaur sk et al.With the title "hepatic arterial chemoembolization using drug-eluting beads in gastrointestinal neuroendocrine tumor metastatic to the liver" and concerned a (b)(6)-year old female patient who experienced severe right upper quadrant pain and intrahepatic biliary dilatation.The patient's medical history included a previous left hepatectomy.No information concerning concomitant medication was provided.On an unspecified date between jun-2004 and jun-2009, the patient received lc bead (300-500 microm) loaded with 100 mg of doxorubicin and contour se particles (500-700 microm) as right lobe drug-eluting bead chemoembolization for metastatic gi neuroendocrine tumor to the liver.On an unspecified date after the drug-eluting bead chemoembolization, the patient presented to the emergency department with severe right upper quadrant pain.An enhanced-ct of the abdomen showed a wedge-shaped perfusion abnormality in the posterior segment of the right lobe, in addition to intrahepatic biliary dilatation.The patient was treated with percutaneous transhepatic cholangiography and internal/external biliary stent placement.The patient subsequently did well and the biliary tube was removed without complication.During follow-up, 501 days after chemoembolization, the patient's disease was classified as an objective response which is defined as a partial or complete tumor response.The events of severe right upper quadrant pain and intrahepatic biliary dilatation are resolved.The authors assessed the event of severe right upper quadrant pain and intrahepatic biliary dilatation as related to the use of lc bead.The company assessed the events of severe right upper quadrant pain and intrahepatic biliary dilatation as serious (hospitalization, intervention required) and the issue of off-label use as non-assessable.Final assessment on 22-jun-2016: follow up information has been requested.The author replied that he cannot provide any further information since the manuscript was published 5 years ago and he no longer has the data.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.The case is linked to cases (b)(4).Case comment: abdominal pain upper, biliary dilatation and off label use are considered unlisted as per lc bead instructions for use.In agreement with the authors, the company considered the events of abdominal pain upper and biliary dilatation as related to the device 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.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: 5684999
• MDR Text Key: 46100300
• Report Number: 3002124545-2016-00040
• 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
• 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: 300-500 MICROM
• 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): Hospitalization; Required Intervention
• Patient Age: 54 YR