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

Model Number 100-300

Device Problem Insufficient Information (3190)

Patient Problems Neurological Deficit/Dysfunction (1982); Dysphasia (2195); Numbness (2415); Test Result (2695)

Event Type  Injury  

Event Description

Report from (b)(6) via medical director of a female, (b)(6) year old patient diagnosed with liver metastases from colorectal cancer.Her liver metastases were treated with chemoembolization with irinotecan loaded dc bead (100-300 microns loaded with 100mg irinotecan).No shunting was identified during angiogram.The patient did not have any previous cardiac medical history.No medical history of stroke.During the procedure the patient experienced difficulty to talk and she complained that she could not feel her leg.A brain mri showed an area of devascularisation compatible with her neurological symptoms.Patient was hospitalized after treatment and her symptoms worsened over a 48 hour period.Follow-up with the hospital is ongoing.

Manufacturer Narrative

Company comment: dc bead loaded with irinotecan was used in the treatment of this patient.The equivalent product lc bead is available in the usa, however, it is not indicated for use with drugs.Company medical review determined that this patient developed stroke probably in the context of non-target embolization to her brain through non-visible hepatic av shunts.The dc bead ifu documents undesirable reflux or passage of dc bead microspheres into normal arteries adjacent to the targeted lesion or through the lesion into other arteries or arterial beds and ischaemic stroke or ischaemic infarction as potential complications of product use.This is therefore an anticipated complication.Investigation into this complaint is ongoing.

• Brand Name: DC BEAD
• Type of Device: EMBOLIC AGENT
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; farnham business park; weydon ln; farnham, surrey GU9 8QL; UK GU9 8QL
• Manufacturer Contact: farnham business park; weydon lane; farnham, surrey GU9 8-QL ; 252732732
• MDR Report Key: 3600376
• MDR Text Key: 4068002
• Report Number: 3002124545-2013-00012
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K094018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2013

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 Expiration Date: 12/01/2016
• Device Model Number: 100-300
• Device Catalogue Number: DC2V103
• Device Lot Number: V10462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2013
• Initial Date FDA Received: 01/30/2014
• 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: DC BEAD WAS LOADED WITH IRINOTECAN PRIOR TO USE
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR