MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD LC 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 Abdominal Pain (1685); Abscess (1690); Anemia (1706); Death (1802); Diarrhea (1811); Dyspnea (1816); Edema (1820); Fatigue (1849); Fever (1858); Hair Loss (1877); Hematoma (1884); Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Neuropathy (1983); Pain (1994); Sweating (2444); Ascites (2596); Constipation (3274)

Event Type  Death  

Manufacturer Narrative

As noted by the author in this publication, the reported toxicities are known and anticipated as part of the tace procedure using deb.The events may be related to the doxorubicin, or the resulting necrosis of the tumor treated.The abnormal laboratory values of hyperglycemia, increased alt are sequelae of abnormal liver function, and in addition are not serious injuries.Biloma and liver abscess are known complications associated with the tace procedure.As stated in the literature, the author believed patient selection to be a factor, noting that patients with multiple lesions had a smaller rate of biloma formation than patients with a single lesion.One patient had pre-existing biliary enteric anastomosis which increases the risk of hepatic abscess formation.The authors also believed the injection technique to be a contributing factor to the increased rate of biloma , and adjusted their patient selection criteria and method of administration accordingly.Lot numbers for the devices used were not reported, therefore a quality investigation into the lots cannot be performed.Disease progression occurs in patients with incurable liver cancer and some patients only have partial response to tace, thus the company considered disease progression and therapeutic response decreased not related to lc bead.The use of lc bead loaded with doxorubicin is considered off label use of the device.There was no report of deficiency or malfunction.

Event Description

Liver abscess [liver abscess]; biloma [biloma]; disease progression [disease progression]; fatigue [fatigue]; anemia [anaemia]; lymphopenia [lymphopenia]; hypotension [hypotension]; edema [oedema]; increased inr [international normalised ratio increased]; fever [pyrexia]; night sweats [night sweats]; alopecia [alopecia]; dry skin [dry skin]; ascites [ascites]; anorexia [decreased appetite]; constipation [constipation]; diarrhea [diarrhoea]; nausea [nausea]; taste alteration [dysgeusia]; hematoma [haematoma]; increased alt [alanine aminotransferase increased]; increased ast [aspartate aminotransferase increased]; increased ap [blood alkaline phosphatase increased]; hyperbilirubinemia [hyperbilirubinaemia]; hypoalbuminemia [hypoalbuminaemia]; hyperglycemia [hyperglycaemia]; hyponatremia [hyponatraemia]; neuropathy [neuropathy peripheral]; abdominal pain (nonspecific) [abdominal pain]; right upper quadrant pain [abdominal pain upper]; pain (other) [pain]; dyspnoea [dyspnoea]; dyspnea on exertion [dyspnoea exertional]; lc beads loaded with doxorubicin [off label use of device]; partial response [therapeutic response decreased].Case description: initial information received on 20-mar-2017: this report is submitted for the article "phase ii study of chemoembolization with drug-eluting beads in patients with hepatic neuroendocrine metastases: high incidence of biliary injury" which reported a high incidence of biliary injury during the course of a non-(b)(4) sponsored phase ii clinical trial beyond which has been previously reported in literature.The article can be summarized as follows: thirteen patients with hepatic metastases from neuroendocrine tumors were treated with lc bead loaded with 50mg of doxorubicin hydrochloride/ vial of lc bead.For a dose of a maximum of 100mg of doxorubicin.The patients were treated with up to 4 procedures in 6 months for a maximum of 6 procedures during the course of 2 years.For simplicity, the doxorubicin loaded lc bead will be referred to as deb as stated in the publication.The patient population was predominantly male (69 %) and ecog status 0 and 1 (54 and 46 %, respectively), and fewer than half were being treated with sandostatin (38 %, n = 5) three patients (23 %) had carcinoid syndrome at presentation (all of whom had remittance of their symptoms after the first deb-tace procedure.The primary cancer sites of origin were pancreas (39 %), other sites (including rectum, gallbladder, ovary, and small bowel) (31 %), and unknown (31 %).The mean largest index tumor size per patient was 5.9 cm.The 13 patients underwent a total of 27 deb-tace procedures[median per patient = 2 (range 1 to 4)].Thirteen patients were included in the toxicity assessment.After the initial deb-tace procedure, all patients experienced at least one toxicity.The most common toxicities (occurring in >30 % of the patients) were fatigue, fever, night sweats, anorexia, abnormal liver function, hyperglycemia, abdominal pain, and bilomas.Grade 3 to 4 toxicities consisted of fatigue (23 %), increased alt (15 %), liver abscess (15 %), hyperglycemia (15 %), abdominal pain (8 %), and bilomas (8 %).Six patients developed bilomas after their initial deb-tace procedure, and one patient developed a biloma after her second deb-tace procedure, resulting in a total biloma incidence of 54 %.Four of the seven patients underwent percutaneous drainage, three for abscess and one for symptoms related to mass effect.(b)(4) will submit a supplemental report if additional information is received.

• Brand Name: LC BEAD
• Type of Device: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback ; lakeview, riverside way,; watchmoor park gu15 3yl; camberley, surrey
• MDR Report Key: 6502859
• MDR Text Key: 73104142
• Report Number: 3002124543-2017-00012
• 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
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2017
• 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
• Treatment: OXILAN (IOXILAN); SANDOSTATIN (OCTREOTIDE ACETATE)
• Patient Outcome(s): Death; Hospitalization; Required Intervention