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

Model Number 105-7100-060

Device Problems Break (1069); Material Separation (1562); Sticking (1597)

Patient Problems Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)

Event Date 06/25/2014

Event Type  Injury  

Event Description

(b)(4).Treatment of a cerebral arteriovenous fistula.The patient presented with global aphasia and hemiplegia.On (b)(6) 2014, the patient underwent onyx embolization treatment.During the onyx injection, it was reported there was 2cm of onyx reflux and the marathon microcatheter got stuck inside the vessel after injecting onyx.Upon removal of the microcatheter, the microcatheter separated at 25cm from the tip and the broken piece was left inside the patient as the rest of the microcatheter was removed from the patient.The physician decided to leave the broken microcatheter tip inside the patient between the external carotid artery and the occipital artery since there was no risk to the patient.Post procedure, the global aphasia and hemiplegia were getting better.Same event as mdr # as 2029214-2014-00435.

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation as they were consumed in the event.The other devices involved are as follows: model: 105-7100-060 / lot: 9852961 dom: 14 jan 2014 exp: 12 nov 2016 (qty.2).(b)(4).

• Brand Name: ONYX, AVM
• Type of Device: LIQUID EMBOLIC
• Manufacturer (Section D): EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: henry to ; 9775 toledo way; irvine, CA 92618 ; 9496801335
• MDR Report Key: 3953028
• MDR Text Key: 21724934
• Report Number: 2029214-2014-00436
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/12/2016
• Device Model Number: 105-7100-060
• Device Lot Number: 9852961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2014
• 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