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 Aneurysm (1708); Hemorrhage/Bleeding (1888)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: zhou, z., xu, k., (b)(6).Parent artery occlusion for ruptured aneurysms in moyamoya vessels or on collaterals.Frontiers in neurology 2023.Doi:10.3389/fneur.2023.1085120 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.See related report #2029214-2023-01928.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

Zhou z, xu k, (b)(6).Parent artery occlusion for ruptured aneurysms in moyamoya vessels or on collaterals.Frontiers in neurology.20 23;14:1085120.Doi:10.3389/fneur.2023.1085120.Medtronic literature review found a report of patient complications in association with onyx, echelon catheter, and marathon catheter.The purpose of this article was to research if parent artery occlusion (pao) is safe for associated aneurysms in moyamoya disease (mmd).A retrospective study was performed for patients with mmd associated with ruptured aneurysms who underwent pao from january 2015 to september 2022.Eleven patients who met the inclusion criteria were enrolled, aged 39¿69 years (mean 54.7 ± 10.4 years), and six patients were male (54.5%, 6/11).The inclusion criteria were as follows: (1) patients had ipsilateral or bilateral mmd associated with ruptured aneurysms, presenting with various intracranial hemorrhages.(2) aneurysms were located in moyamoya vessels or on collaterals, including the distal anterior choroidal artery (acha), lenticulostriate artery (lsa), distal posterior cerebral artery (pca) and middle meningeal artery (mma).(3) there was a path to catheterize the aneurysm to perform pao.Those aneurysms on the major trunk of the intracranial arteries, in which the parent artery can be preserved during evt, were excluded.Those aneurysms in which the parent artery was too thin, that could not be distinguished or in which evt failed or abandoned were excluded.However, the clinical data of these patients were still summarized to provide more information about associated aneurysms in mmd.All patients were treated under general anesthesia via a transfemoral approach.Digital subtraction angiography (dsa) with three-dimensional reconstruction confirmed the angioarchitecture of the aneurysm.After the best projection degree showed both the aneurysm neck and the parent artery, under roadmap guidance, the microcatheter was used to catheterize the parent artery and the aneurysm.If the parent artery was not tortuous or thick enough and if the aneurysm was not far from the major trunk artery, an echelon-10 microcatheter (medtronic, irvine, california, usa) under 0.014-inch microguidewire navigation was used to perform pao with coiling.If the echelon-10 microcatheter was too thick to pass through the parent artery or if the aneurysm was too far from the major trunk artery and periphery, a soft marathon microcatheter with a 1.5f tip under 0.012- or 0.010-inch microguidewire navigation was used to perform pao with casing onyx.After the microcatheter was positioned in the proximal segment of the parent artery or in the aneurysm, super selective angiography was performed to confirm the position of the microcatheter tip.Then, pao can be performed by coiling both the parent artery and the aneurysm, coiling only the proximal segment of the parent artery, or occluding both the parent artery and the aneurysm with onyx casting.Among the 11 aneurysms, pao by coiling was performed on 7 (63.6%, 7/11), and onyx casting was performed on 4 (36.4%, 4/11).The article does not state any technical issues during use of the medtronic devices.The following intra- or post-procedural outcomes were noted: -2 (18.2%, 2/11) suffered intraoperative hemorrhagic complications, and continuous evt stopped the bleeding.Hemorrhagic complications were due to fragile parent artery rupture -after pao, 10 (90.9%, 10/11) patients recovered well without new postoperative deficits, and 1 (9.1%, 1/11) patient who suffered a complication developed hemiparesis.-2 (18.2%, 2/11) had an mrs score of 0, 5 (45.5%, 5/11) had an mrs score of 1, and 4 (36.4%, 4/11) had an mrs score of 2.All patients had good outcomes with a modified rankin scale score of 0¿2.-5 patients had unsuccessful evt or abandoned it altogether ; the cause of unsuccessful or abandoned evt was aneurysm regression in 1 patient, no path of evt in 3 patients, and a poor state in 1 patient.The patient with a poor state had no chance of treatment and died.Two patients accepted conservative treatment, 1 patient suffered re-hemorrhage after a follow-up of 48 months, and 1 patient was still in a stable state.Two patients accepted surgical resection of the aneurysm and were in a stable state.

• 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: 17863200
• MDR Text Key: 324832671
• Report Number: 2029214-2023-01929
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2023

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: 09/22/2023
• Initial Date FDA Received: 10/03/2023
• 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: 52 YR
• Patient Sex: Male