MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

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

Patient Problems Necrosis (1971); Neuropathy (1983)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Dolas, i., unal, t.C., gulsever, c.I., sahin, d., huseynov, h., barburoglu, m., ozturk, o., can, h., adiyaman, a.E., dagdeviren, h.E., sabanci, p.A., aydoseli, a., aras, y., sencer, a., sencer, s.Endovascular treatment of posterior circulation aneurysms: results from a single-team experience of 81 cases including 13 flow diversion treatment.Neurocirugia.2023.34(4):168¿176.Doi: (b)(6) 2016/j.Neucie.2022.11.022.Medtronic literature review found a report of patient complications in association with axium coils, solitaire stents used in stent-assisted coiling, and pipeline flow diverters.The purpose of this article was to present the results of a series of endovascularly treated posterior circulation aneurysms.A total of 81 patients who underwent endovascular treatment of posterior circulation aneurysms.Among the included patients, 50 were female and 31 were male, and the mean age was 57.4 years.Among the 81 aneurysms, 40 aneurysms were treated with stent-assisted coiling, 1 aneurysm was treated by parent artery occlusion, 2 aneurysms were coiled using balloon assistance, 24 aneurysms were coiled primarily, 1 patient had an unsuccessful treatment attempt, and 13 aneurysms were treated with flow-diverter stents or stent monotherapy.It is unclear how many of these events occurred with the use of axium, solitaire, or pipeline devices.The article does not state any technical issues during use of the axium, solitaire, or pipeline devices.- one patient developed right hemiparesis due toa left thalamic infarction a few hours after the procedure.This patient¿s neurological status was classified as mrs 2 upon discharge from the hospital and was mrs 0 on her last follow up.- two elderly patients who were treated for fusiform aneurysms of the basilar artery with flow-diverter stents were admitted to the emergency room multiple times with ischemic lesions of the brain stem.- among the two patients who has basilar tip aneurysms, one who received stent-assisted coiling underwent retreatment 6 months later, and the other under-went retreatment 2 years later.Moreover, according to initial angiograms four raymond and roy (r<(>&<)>r) 2 patients were re-canalized during the follow-up period, and their aneurysm size increased, requiring retreatment.One patient with prior stent-assisted coiled right superior cerebellar artery (sca) aneurysm was recanalized and required retreatment with a second coil placement.Another patient who presented with sah from a posterior cerebral artery (pca) aneurysm that was previously coiled underwent retreatment with a flow-diverting stent a year later.

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.See 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: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 18211120
• MDR Text Key: 329034400
• Report Number: 2029214-2023-02282
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2023

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-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/27/2023
• 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