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 Insufficient Information (4580)

Event Date 08/01/2017

Event Type  Death  

Manufacturer Narrative

Zhao r, duan g, yang p, et al.Endovascular aneurysm treatment with the numen coil embolization system: a prospective randomized controlled open-label multicenter noninferiority trial in china.World neurosurgery.2022;160:e23-e32.Doi:10.1016/j.Wneu.2021.11.067 this value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.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

Zhao r, duan g, yang p, et al.Endovascular aneurysm treatment with the numen coil embolization system: a prospective randomized controlled open-label multicenter noninferiority trial in china.World neurosurgery.2022;160:e23-e32.Doi:10.1016/j.Wneu.2021.11.067 medtronic literature review found a report of patient complications in association with axium coils.The purpose of this article was to investigate the safety and efficacy of the numen coil compared with the axium coil in the treatment of intracranial systems.The study was a prospective randomized controlled open-label noninferiority trial (catch - coil application trial in china) conducted in 10 centers across china, and patients who fulfilled the inclusion and exclusion criteria were randomized 1:1 to either the test group (numen) or a control group (axium).The primary outcome was based on successful aneurysm occlusion at 6 months follow-up, whereas secondary outcomes included technical success, the recanalization and retreatment rates, and the rate of serious adverse events (saes) at 6 months and 12 months follow-up.Complete occlusion was defined as an aneurysm occlusion degree with a raymond score of i, whereas the recanalization rate was defined as the percentage of patients with a decreased aneurysm occlusion degree at the follow-up period compared with the immediate postoperative period.The safety outcome measurements included the retreatment rate as well as the clinical outcome worsening rate at and 12 months postoperatively and procedure-related or device-related adverse events at 30 days and 6 and 12 months after the treatment, whereas the clinical outcome worsening rate was defined as the proportion of patients with a modified rankin scale score >2 with greater than or equal to 1 point higher than the preprocedural score.The obtained evaluation results were the final score of those patients who had not completed either 6 or 12 months of follow-up because of death or saes related to the surgical procedure or the treatment device.A total of 334 enrolled catch trial patients¿ data were included in the full analysis set (fas), except for 16 patients who were excluded because of withdrawal of informed consent (5 patients), nonconformance with inclusion and exclusion criteria (8 patients), and nonuse of the coil (3 patients) according to their random allocation.There were 166 subjects  in the axium control group that underwent all necessary procedures.There were 108 female patient's and 58 males.The mean age was 56.15 years.Medical history of these subjects included 28 with cerebral infarction, 10 with coronary artery disease, 88 with hypertension, 13 with hypercholesterolemia, 12 with diabetes, 32 with current/previous smoking, and 23 with current/previous drinking.The article does not state any technical issues during use of the axium coils.The following intra- or post-procedural outcomes were noted: -overall mortality during the 30 days follow-up period was 3/166.Mortality was proportional to the procedure used in 2/166 patients.Device mortality was 1.20%.

• 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: 15911603
• MDR Text Key: 304775870
• Report Number: 2029214-2022-02044
• Device Sequence Number: 1
• Product Code: HCG
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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
• Date Manufacturer Received: 11/21/2022
• 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): Death
• Patient Age: 56 YR
• Patient Sex: Female