MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED LC BEAD; EMBOLIC AGENT

Model Number LC BEAD 70-150

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

Patient Problems Death (1802); Ascites (2596)

Event Type  Death  

Event Description

Initial report received via us msl.Add'l data relating to the patient death received on (b)(6) 2014.Patient with er+pr+hr2-breast cancer diagnosed at age (b)(6) and controlled by hormone therapy until liver metastases were diagnosed at age (b)(6).Patient had concomitant metastases to bone.Pt received multiple different lines of systemic chemotherapy but metastases in liver did not respond.Patient had received no prior liver directed therapy.At the time of treatment the patient had infiltrative liver metastases with pseudocirrhosis and >75% liver involvement.Pt received two tace treatments of 70-150 beads loaded with 150 mg doxorubicin, the first on (b)(6) 2012, to treat the right lobe and the second on the (b)(6) 2012, to treat the left lobe.Following the second tace the patient's bilirubin continued to rise, the patient developed ascites and died within 3 weeks due to liver failure, progression of cancer and decompensation.

Manufacturer Narrative

Lc bead loaded with doxorubicin was used in the treatment of this patient.Lc bead is not indicated for use with drugs in the usa.The device has not been sent to the mfr for eval.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.The investigation into this report is ongoing.Company medical assessment: this patient had very extensive involvement of the liver with tumor prior to the procedure.It is impossible to know if liver failure would have occurred due to disease progression anyway or if the chemoembolization procedure triggered the liver failure.Whilst the device did not malfunction, it could be argued that this patient had too much disease for safe tace, therefore, implying a potential "user error." therefore, this case was assessed as medically reportable.Patient continued involvement in a further clinical study prior to tace procedure.

• Brand Name: LC BEAD
• Type of Device: EMBOLIC AGENT
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; chapman house, farnham bus.; park, weydon ln; farnham, surrey england ; UK
• Manufacturer (Section G): BIOCOMPATIBLES U.K. LIMITED; chapman house, farnham bus.; park, weydon ln; farnham, surrey england ; UK
• Manufacturer Contact: chapman house, farnham bus.; park, weydon ln; farnham, surrey england ; 252732732
• MDR Report Key: 3836159
• MDR Text Key: 4453549
• Report Number: 3002124545-2014-00003
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LC BEAD 70-150
• Device Catalogue Number: VE120GS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/25/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: LC BEAD WAS LOADED WITH DOXORUBICIN PRIOR TO USE.
• Patient Outcome(s): Death
• Patient Age: 55 YR