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 Problem Pain (1994)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

B.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.No specific device information provided.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.

Event Description

Brown, e.C., texakalidis, p., stedelin, b., tora, m.S., rindler, r.S., grossberg, j.A., peterson, r.B., campbell, m., cetas, j.S., boulis, n.M., raslan, a.M.Dural arteriovenous fistula presenting as trigeminal neuralgia: 2 case reports and review of the literature.World neurosurg.2020.139:298-308.Doi: 10.1016/j.Wneu.2020.02.083.Summary: dural arteriovenous fistulae (davfs) can sporadically compress the root entry zone of the trigeminal nerve or the gasserian ganglion and therefore be a rare cause of isolated or complicated trigeminal neuralgia (tn).We describe 2 cases of tn related to davf treated similarly with transarterial embolization but with divergent outcomes.Further, we completed a comprehensive literature review of previously reported cases to date.A sparse but growing literature with regards to this specific and rare but salient cause of tn was noted.The type of davf most commonly found to cause tn was that of a tentorial nidus, a lesion generally accepted to be at high risk of hemorrhage and in need of urgent treatment.This warrants imaging for new tn presentations to ensure that a dangerous lesion does not represent the underlying cause, especially when the tn symptoms are comorbid with other symptoms such as a bruit.Treatments pursued span the range of open surgery, endovascular treatment, and radiosurgery with great success in treating both the tn symptoms, as well as the rupture risk of the davf itself in most cases.Indeed, endovascular approaches are becoming more widely employed for these cases over time, often resolving the abnormality on first treatment attempt.Other cases reach resolution after employing a combination of treatment modalities.This work highlights that davfs, particularly the tentorial type, are capable of causing tn symptomatically identical to that of other etiologies and that treatment of the davf itself is often sufficient.Reported events: the patient underwent endovascular transarterial embolization with posttreatment surveillance imaging demonstrating complete obliteration of the dural avf.At 1-month follow-up, the patient reported complete resolution of pulsatile tinnitus; however, her facial pain remained unchanged.The patient was scheduled for surgical microvascular decompression 3 months later.No arterial compression was noted at the time of surgery, but 2 large petrosal veins were noted to course medial and lateral to the fifth cranial nerve at its rez.These were coagulated to shrink but maintain their lumen canalization until there was no visible compression.Three months postoperatively, the patient describes dense right-sided facial numbness with continued but paroxysmal pain.

• 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: 17780352
• MDR Text Key: 323825567
• Report Number: 2029214-2023-01775
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2023

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: 09/20/2023
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female