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

Model Number 100-300 MICROM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Liver Damage/Dysfunction (1954)

Event Date 04/20/2016

Event Type  No Answer Provided  

Event Description

Hepatic function abnormal [hepatic function abnormal].Case description: initial information received on 10-jun-2016: this spontaneous medical device report was received from a healthcare professional via a business partner concerning a (b)(6) female patient.The patient's medical history includes breast cancer, hepatic failure, multiple tumors (3 or more) and three previous transcatheter arterial chemoembolization (tace) (once with dc bead).The patient's pre-treatment child-pugh score was 8 points and total bilirubin was 2.8.Concomitant medications included epirubicin 50 mg on (b)(6) 2016 loaded into the dc beads.The patient received one vial of dc bead (100-300 microm) loaded with epirubicin 50 mg on (b)(6) 2016 at the embolization site noted as s4/segment and right lobe.The degree of embolization (the rate of disappearance of the contrast medium (with 5 heartbeats as a reference) was rated as fast.Lot numbers and expiration dates not provided.On (b)(6) 2016, the patient had oedema and hepatic function decreased (total bilirubin 10.5).Hepatic function abnormal developed.On an unspecified later date, the event of hepatic function abnormal was not recovering, and treatment was shifted to palliative care.The outcome of hepatic function abnormal was "not recovered." the reporter assessed the event as possibly related to the use of dc bead.The company assessed the event of hepatic function abnormal as medically significant and an unanticipated serious deterioration in the state of health.Follow-up information is being requested.Case comments: hepatic function abnormal is considered unlisted according to the dc bead current reference safety information.In agreement with the reporter, the company considers the event of hepatic function abnormal as possibly related to the use of dc bead.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.

Event Description

Hepatic function abnormal [hepatic function abnormal].Case description: initial information received on 10-jun-2016: this spontaneous medical device report was received from a healthcare professional via a business partner concerning a (b)(6) female patient.The patient's medical history includes breast cancer, hepatic failure, multiple tumors (3 or more) and three previous transcatheter arterial chemoembolization (tace) (once with dc bead).The patient's pre-treatment child-pugh score was 8 points and total bilirubin was 2.8.Concomitant medications included epirubicin 50 mg on (b)(6) 2016 loaded into the dc beads.The patient received one vial of dc bead (100-300 microm) loaded with epirubicin 50 mg on (b)(6) 2016 at the embolization site noted as s4/segment and right lobe.The degree of embolization (the rate of disappearance of the contrast medium (with 5 heartbeats as a reference) was rated as fast.Lot numbers and expiration dates not provided.On (b)(6) 2016, the patient had oedema and hepatic function decreased (total bilirubin 10.5).Hepatic function abnormal developed.On an unspecified later date, the event of hepatic function abnormal was not recovering, and treatment was shifted to palliative care.The outcome of hepatic function abnormal was "not recovered." the reporter assessed the event as possibly related to the use of dc bead.The company assessed the event of hepatic function abnormal as medically significant and an unanticipated serious deterioration in the state of health.Follow-up information is being requested.Follow-up information was received on 14-sep-2016: follow-up information is being sought.As of 14-sep-2016, no additional information has been received.Case comments: hepatic function abnormal is considered unlisted according to the dc bead current reference safety information.In agreement with the reporter, the company considers the event of hepatic function abnormal as possibly related to the use of dc bead.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 loaded with epirubicin treatment was considered off-label use of dc bead, since dc bead is indicated only for use with doxorubicin or irinotecan and not with epirubicin.

Event Description

Hepatic function abnormal [hepatic function abnormal]; oedema [oedema] ; dc bead loaded with epirubicin [off label use of device].Case description: initial information received on (b)(6) 2016: this spontaneous medical device report was received from a healthcare professional via a business partner concerning a (b)(6) female patient.The patient's medical history includes breast cancer, hepatic failure, multiple tumors (3 or more) and three previous transcatheter arterial chemoembolization (tace) (once with dc bead).The patient's pre-treatment child-pugh score was 8 points and total bilirubin was 2.8.Concomitant medications included epirubicin 50 mg on (b)(6) 2016 loaded into the dc beads.The patient received one vial of dc bead (100-300 microm) loaded with epirubicin 50 mg on (b)(6) 2016 at the embolization site noted as s4/segment and right lobe.The degree of embolization (the rate of disappearance of the contrast medium (with 5 heartbeats as a reference) was rated as fast.Lot numbers and expiration dates not provided.On (b)(6) 2016, the patient had oedema and hepatic function decreased (total bilirubin 10.5).Hepatic function abnormal developed.On an unspecified later date, the event of hepatic function abnormal was not recovering, and treatment was shifted to palliative care.The outcome of hepatic function abnormal was "not recovered." follow-up information is being requested.Follow-up information was received on (b)(6) 2016: follow-up information is being sought.As of (b)(6) 2016, no additional information has been received.Follow-up information was received on (b)(6) 2016: this follow-up report was received from a healthcare professional via a business partner.The outcome of abnormal hepatic function was unknown.The patient became a home care patient.After revision of the case, oedema reported in the initial report was added as an event and dc bead (100-300 micro]m) loaded with epirubicin 50 mg treatment was considered as off-label use of dc bead, since dc bead is indicated only for use with doxorubicin or irinotecan and not with epirubicin.The reporter assessed the events of hepatic function abnormal and oedema as possibly related to the use of dc bead and did not provide an assessment for the off label use.The company assessed the events of hepatic function abnormal and oedema as medically significant and an unanticipated serious deterioration in the state of health, and off label use of device as non-serious.Follow-up is complete and no further information is anticipated.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.Case comments: hepatic function abnormal, oedema and off label use of device are considered unlisted according to the dc bead current reference safety information.In agreement with the reporter, the company considers the events of hepatic function abnormal and oedema as possibly related to the use of dc bead.The off label use of device is not an adverse event per se but a special scenario and therefore not assessable.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.

• Brand Name: DC 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 ; 1252 732 7
• MDR Report Key: 5735601
• MDR Text Key: 47757707
• Report Number: 3002124545-2016-00047
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-300 MICROM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• 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
• Patient Age: 66 YR