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 Ischemia (1942)

Event Date 07/19/2021

Event Type  Injury  

Event Description

Mendez-ruiz, a., guerrero, w.R., szeder, v., farooqui, m., zevallos, c.B., quispe-orozco, d., ortega-gutierrez, s.Endovascular embolization of high-grade cerebral dural arteriovenous fistulas - assessment of long-term recurrences.Interventional neuroradiology.2022.Vol.28(4) 411¿418.Doi: 10.1177/15910199211038277 summary: endovascular therapy has shown to be safe and effective for the treatment of cerebral dural arteriovenous fistulas; however, recurrence after complete occlusion is not uncommon, and the timing of recurrence remains unknown.Methods: a retrospective single-center cohort study was conducted from january 2005 to december 2020.Patients with highgrade (=borden ii¿cognard iib) dural arteriovenous fistulas treated with endovascular therapy were included in this study.Clinical and angiographic characteristics were collected for hospitalization and at follow-up.Results: a total of 51 patients with a median age of 61 years were studied; 57% were female.High-flow symptoms related to the high-flow fistula were the most common presentation (67%), and 24% presented with intracranial hemorrhage.Transverse-sigmoid (26%) and cavernous (26%) sinuses were the most common dural arteriovenous fistula locations.A total of 40 patients (70%) had middle meningeal arterial feeders and 4 (7%) had deep cerebral venous drainage.The mean number of embolization procedures per patient was 1.4.Transarterial access was the most frequent approach (61%).Onyx alone was the most common embolic agent (26%).Complete occlusion rate was achieved in 46 patients (80.1%).Last mean radiographic follow-up time was 26.7 months for all 57 dural arteriovenous fistulas.Dural arteriovenous fistula recurrence after radiographic resolution at last treatment was seen in six cases (6/46, 13.1%).Mean time for recurrence was 15.8 months.Mean time of last clinical follow-up was 46.1 months for the 51 patients (100%).A total of 10 (20%) experienced any procedural complications, among which two (4%) became major thromboembolic events.Reported events: two (3.9%) major symptomatic thromboembolic events and residual deficits.

Manufacturer Narrative

B.3.Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.See attached literature article.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.

• 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: 17650267
• MDR Text Key: 322277071
• Report Number: 2029214-2023-01527
• 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: 08/30/2023

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: 08/03/2023
• Initial Date FDA Received: 08/30/2023
• 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