MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX; AGENT, INJECTABLE, EMBOLIC

Model Number UNK-NV-ONYX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Pain (1994); Visual Disturbances (2140); Dizziness (2194)

Event Date 05/14/2020

Event Type  Injury  

Event Description

Waleed brinjikji, harry j.Cloft, kelly flemming, giuseppe lanzino; world neurosurgery; 2020; 143:46-50; evolution of developmental venous anomalies in the setting of a torcular dural arteriovenous fistula and cerebrofacial venous metameric syndrome; doi.Org/10.1 016/j.Wneu.2020.06.035.Medtronic received information in a literature article that a patient treated with onyx had complications.The article describes the evolution of a developmental venous anomaly (dva) over time in a patient with a complex intracranial vascular malformation. a 26-year-old male patient initially presented with a scalp vascular malformation and was later diagnosed to have a torcular dural arteriovenous fistula resembling a dural sinus malformation. a catheter angiogram showed the left periorbital venous malformation as well as the left parietal arteriovenous malformation.A torcular dural arteriovenous fistula (davf) supplied predominantly by the posterior meningeal artery also was identified.The torcular davf was subsequently partially embolized using onyx.Repeat angiography 2 years later demonstrated progression of the davf with new arterial supply from the meningohypophyseal trunks, bilateral occipital arteries, posterior divisions of the middle meningeal arteries bilaterally, and dural supply from both posterior cerebral arteries.Mri at the same time interval confirmed progression of the dural fistula as well.Additional embolizations over the course of 3 years failed to achieve complete obliteration of the fistula, and he remained asymptomatic.He was referred to another institution because of progressive neurologic symptoms, including face pain and dizziness as well as visual obscurations. mri examination at the time demonstrated a number of interesting imaging findings, all of which were new compared with his baseline mri. first, there was marked enlargement of the torcular compared with the baseline mri, consistent with definite progression of the davf.Magnetic resonance venography confirmed these findings and also demonstrated an extensive davf extending from the torcula along the left transverse sinus.Over the course of 5 years, a new persistent falcine sinus had developed that wasnot present on the initial mri. there was engorgement of the pre-existing dva draining the right lentiform nucleus and thalamus as well.Lastly, there was interval development of numerous cavernous malformations in both cerebral hemispheres, cerebellum, right cerebral peduncle and medulla, none of which were present 5 years earlier on t2*-weighted imaging.There were all in the venous radicles of the dva.

Manufacturer Narrative

See attachments for literature article.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ONYX
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17741193
• MDR Text Key: 323358705
• Report Number: 2029214-2023-01700
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

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 Model Number: UNK-NV-ONYX
• Device Catalogue Number: UNK-NV-ONYX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/13/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male