MAUDE Adverse Event Report: EV3 NEUROVASCULAR ONYX AVM; LIQUID EMBOLIC

Model Number 50067-060-1

Device Problems Entrapment of Device (1212); Material Separation (1562); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/21/2014

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was consumed in the event.

Event Description

Treatment of an avm (arteriovenous malformation) off of the vert.On (b)(6) 2014, the patient underwent onyx embolization treatment.During the procedure, it was reported the distal segment of the catheter separated and became lodged in the pica (posterior inferior cerebellar artery).The physician stated there was friction experienced during the injection.On (b)(6) 2014, it was reported the patient was doing fine and the broken catheter segment remains in the patient with no future plans on removing it.Same event as mdr# 2029214-2014-00486.

• Brand Name: ONYX AVM
• Type of Device: LIQUID EMBOLIC
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: michael nguyen ; 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4036879
• MDR Text Key: 21167546
• Report Number: 2029214-2014-00487
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2014

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: Other
• Device Expiration Date: 07/23/2016
• Device Model Number: 50067-060-1
• Device Lot Number: 9778448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2013
• 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
• Patient Outcome(s): Disability