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 Problem Thrombosis/Thrombus (4440)

Event Date 07/30/2018

Event Type  Injury  

Event Description

Onal y, acunas b, samanci c, et al.Preliminary results of stent-assisted coiling of wide-necked visceral artery aneurysms via self-expandable neurointerventional stents.Journal of vascular and interventional radiology.2019;30(1):49-53.Doi:10.1016/j.Jvir.2018.0 7.027 medtronic literature review found a report of patient complications in association with axium coils.The purpose of this article was to determine technical feasibility and results of stent-assisted coiling of visceral artery aneurysms (vaas) with self-expandable leo plus neurointerventional stent.There were 11 patients with vaas included in the study.Axium coils were used in an unknown number of the procedures for coiling.The article does not state any technical issues during use of the axium coil.The following intra- or post-procedural outcomes were noted: in 1 patient, thrombosis of the distal part of the stent was seen just after deployment; 1 mg of tirofiban was selectively infused from the microcatheter inside the stent, and the thrombosis resolved, but tirofiban infusion was continued that night.To eliminate the possibility of clopidogrel resistance, the patient¿s antiaggregant agent was switched to ticagrelor, and the patient was discharged without any problem.The patient with stent thrombosis was hospitalized for 3 days for tirofiban injection.

Manufacturer Narrative

Onal y, acunas b, samanci c, et al.Preliminary results of stent-assisted coiling of wide-necked visceral artery aneurysms via self-expandable neurointerventional stents.Journal of vascular and interventional radiology.2019;30(1):49-53.Doi:10.1016/j.Jvir.2018.0 7.027 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: 16281626
• MDR Text Key: 308614364
• Report Number: 2029214-2023-00156
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2023

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: 01/25/2023
• Initial Date FDA Received: 02/01/2023
• 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: 64 YR
• Patient Sex: Female