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

Model Number NOT REPORTED

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562); Physical Resistance (2578)

Patient Problems Stroke/CVA (1770); Extubate (2402)

Event Date 06/25/2014

Event Type  Injury  

Event Description

Treatment of a cerebellar avm (arteriovenous malformation).The patient's anatomy was tortuous.On (b)(6) 2014, the patient underwent onyx embolization treatment.Post onyx injection, it was reported the distal tip of the catheter separated with a piece of onyx as it was being pulled with some resistance and they (catheter tip and piece of onyx) migrated into the mid superior cerebellar artery causing flow arrest.Prior to catheter separation, it was reported the physician embolized one portion of the avm without incident and pulled the marathon to access a different portion of the lesion through the superior cerebellar artery.The onyx embolization was successful with 1cm or less of reflux prior to the separation.On (b)(6) 2014, it was reported the patient suffered a stroke and was in poor condition.On (b)(6) 2014, the patient was extubated and doing well according to the physician.On (b)(6) 2014, it was reported there will be no attempts to remove the broken catheter tip and onyx as the patient is making progress.Same event as mdr# 2029214-2014-00431.

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it was consumed in the event.(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: 3953667
• MDR Text Key: 4624292
• Report Number: 2029214-2014-00432
• 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: 06/25/2014

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 Model Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 49 YR