MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD DC BEAD; HCG/KRD

Model Number 100 - 300 MICROM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pulmonary Embolism (1498); Liver Damage/Dysfunction (1954); Therapeutic Response, Decreased (2271)

Event Type  No Answer Provided  

Manufacturer Narrative

Dc bead (with irinotecan 100-200 mg) 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.

Event Description

Progressive liver disease [disease progression] pulm embolus [pulmonary embolism] dc bead used for liver metastases from uveal melanoma [off label use of device.] case description: initial information received on (b)(6) 2015: this literature medical device report was published in 2015 in the journal cardiovascular and interventional radiology by carling et al., with the title "transarterial chemoembolization of liver metastases from uveal melanoma using irinotecan-loaded beads: treatment response and complications", it concerned a (b)(6) female patient affected by liver metastases from uveal melanoma (um).The patient was part of a retrospective analysis conducted on 14 patients diagnosed with liver metastases from um.All patients were diagnosed with liver metastases on annual contrast-enhanced ultrasound.Subsequently contrast enhanced ct, contrast-enhanced mri and pet were performed for assessment of liver involvement and detection of extra-hepatic disease.All patients had a patent portal vein and an eastern cooperative oncology group (ecog) grade of 0 or 1.In all procedure arterial femoral access with 4f or 6f sheet was used.Initial angiographic series were performed in both the celiac trunk and the superior mesenteric artery for evaluation of hepatic artery anatomy.Selective catheter position for lobar administration of beads was achieved using microcatheters), and beads were injected distally to the cystic artery when possible.To achieve a safe and complete lobar treatment, segmental catheterizations were necessary in some cases due to anatomic variants.In each procedure, beads loaded with irinotecan were mixed with 10-15 ml iodine contrast and injected slowly, following 1-3 ml of intra-arterial lidocaine (10 mg/ml).Experienced interventional radiologists performed the procedures.The patients routinely had an intravenous pump to administer 1 mg ketobemidone every eight minutes during the procedure.Other applied periprocedural drugs included intravenous diazepam and metoclopramide.Antibiotic agents were not routinely administered.The postprocedural median hospitalization was one day (range 1-4).On (b)(6) 2011 the patient received debiri tace treatment using dc beads 100-300microm loaded with 100mg of irinotecan (batch number and expiration date were unknown) for lever metastases from uveal melanoma.On an unspecified date after debiri procedure the patient experienced progressive liver disease and pulmonary embolus.The patient recovered from the event pulmonary embolus on an unspecified date.But at the time of the report did not recover from the progressive liver disease.The reporting physician considered the event progressive liver disease serious, causing a persistent disability, and the event pulmonary embolus non serious.The reporting physician considered the events related to dc bead.However he stated that both events experienced by the patient could be related to the disease itself, which was extensive.Case comment: this case reports the use of dc bead with irinotecan for liver metastases from uveal melanoma (off-label use).The event progressive liver disease is considered unlisted according to the current instruction for use of dc bead.The event pulmonary embolism is considered listed according to the current instruction for use of dc bead.The company in agreement with the reporting physician considers the events progressive liver disease and pulmonary embolism related to the treatment.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.(b)(4).Final assessment (b)(6) 2015: a (b)(6) patient with liver metastases from a primary ocular melanoma was treated with debiri using dc beads.At an unknown time after the treatment, the patient developed progressive liver failure and a pulmonary embolus.No further information is available about this case.The treating physician felt the patient's progressive hepatic dysfunction was due to progression of the underlying disease (which was characterized as "extensive").While we do not know the precise temporal course of events, the treating physician's assessment does represent the most likely cause of events.No device failure has been identified as a result of these adverse event.No further follow up information is expected and it has been assessed that no corrective action is necessary at this time and the report is considered final.

• Brand Name: DC BEAD
• Type of Device: HCG/KRD
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham,, surrey GU9 8 QL; UK GU9 8QL
• 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
• MDR Report Key: 5297106
• MDR Text Key: 33483329
• Report Number: 3002124545-2015-00099
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• 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: 12/03/2015
• 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: KETOBEMIDONE (KETOBEMIDONE)
• Patient Outcome(s): Disability
• Patient Age: 40 YR