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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Anemia (1706); Diarrhea (1811); Fatigue (1849); Fever (1858); Gastritis (1874); Hair Loss (1877); Liver Damage/Dysfunction (1954); Nausea (1970); Vomiting (2144); Weight Changes (2607); Test Result (2695); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lc bead was reported to have been used in the treatment of this patient.Lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The study design ((b)(6)) stated patients were treated with lc beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.Lc bead loaded with doxorubicin hydrochloride is an off-label use in the usa.The author of the article stated 1 patient was observed with post-tace syndrome which required supportive care and therefore we are reporting this case to you.All other reported events were either not related to the device (2 patients died) or were of a non-serious nature.All events are anticipated harms listed in the risk management documentation and ifu.No device malfunction was reported.No batch review was possible for this case as the batch number could not be ascertained.No product malfunction/deficiency has been identified.No corrective/preventative action has been identified.Follow-up information was requested, but has not been received to date.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.(b)(4).
Event or Problem Description
As part btg's post market surveillance activities a review of literature article "single-centre pase ii trial of transarterial chemoembolization with drug-eluting beads for patients with unresectable hepatocellular carcinoma" author diane k reyes et al was performed.This is the published paper from study (b)(6).Twenty patients with unresectable hcc were treated with lc beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media.They were assessed at 1 month and 3 month follow-ups.The paper described "an" serious adverse event in 1 patient with post-tace syndrome which required supportive care, two patients who died (not device related), and non-serious adverse events in 19 patients.Serious adverse events - related: a post-tace syndrome was observed only in 1 patient that required supportive care.Serious adverse events - not related: 1 patient died of multiorgan failure.The patient experienced "diarrhead" and "deydration" after deb-tace2, was treated at an outside facility with "diurectis" for persistent edema, but remained "hypovolemc" and "hdypotensive".At that time, she was placed on comfort measures.The other patient died of rapid progression of liver disease that had taken plac between the baseline inclusion assessment and the first treatment.Neither death was attributed to the deb-tace procedure.Non-serious adverse events in 19 patients: postembolization syndrome; fatigue; pain-abdomen; fever; nausea/vomiting; anemia; leukocytopenia (below grade 3); thrombocytopenia; alt/ast elevation; anorexia; weight loss; alopecia; decreased libido; diarrhea; gastroenteritis; pancreatitis; cholecystitis.Lc bead loaded with doxorubicin is an off-label application.All listed adverse events are anticipated harms associated with deb-tace and referenced in the risk management documentation and ifu.No device malfunction was reported.

• Brand Name: LC BEAD
• Common Device Name: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 8037192
• Report Number: 3002124543-2018-00049
• Device Sequence Number: 1435712
• Product Code: KRD
• UDI-Device Identifier: 05060116920185
• UDI-Public: 5060116920185
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K094018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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
• Operator of Device: Health Professional
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention