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

Model Number 105-7100-060

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/20/2014

Event Type  Injury  

Manufacturer Narrative

Updated information: the total number of onyx vials that were used in the event was 3 and they all had the same part and lot numbers.Three empty onyx vials were returned and the evaluation could not determine the cause of the event.(b)(4).

Event Description

Treatment of an aaa (abdominal aortic aneurysm) type ii endoleak (blood flow into the aneurysm sac due to opposing blood flow from collateral vessels).On (b)(6) 2014, the patient underwent an off label onyx embolization treatment.The patient was on heparin.During the onyx treatment, it was reported that a piece of the onyx cast separated into the ivc (inferior vena cava) and travelled up the right ventricle as the physician attempted to retract the microcatheter to determine if the microcatheter was stuck in the onyx cast.Prior to the separation, there was approximately 1-2 cm of reflux seen surrounding the tip of the catheter.Upon follow-up, the onyx material had moved from the right ventricle into the lungs.The onyx was observed to be staying in one location for 10 minutes, so it was decided to leave it there.The patient was admitted for 23 hour observation in stable condition and the onyx cast was observed to be in the lungs the next day.The patient was in good condition and was placed on coumadin.

Manufacturer Narrative

The device involved in the event has not been returned for evaluation.(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: 3745719
• MDR Text Key: 19915099
• Report Number: 2029214-2014-00209
• 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,Followup
• Report Date: 03/20/2014

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: Physician
• Device Expiration Date: 09/10/2016
• Device Model Number: 105-7100-060
• Device Lot Number: 9799972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2013
• 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