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 Intracranial Hemorrhage (1891); Hemorrhagic Stroke (4417)

Event Date 12/10/2022

Event Type  Death  

Manufacturer Narrative

G2: citation: authors: khumtong, r., thuncharoenkankha, t., riabroi, k., sakarunchai, i., wichaitum, j., & liabsuetrakul, t.Changes in modified raymond¿roy classification occlusion classes and predictors of recurrence-free survival in patients with intracranial aneurysms after endovascular coil embolization.Journal of vascular & interventional radiology 4 2023.Doi:10.1016/j.Jvir.2022.12.028.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.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

Khumtong r, thuncharoenkankha t, riabroi k, sakarunchai i, wichaitum j, liabsuetrakul t.Changes in modified raymond¿roy classification occlusion classes and predictors of recurrence-free survival in patients with intracranial aneurysms after endovascular coil embolization.Journal of vascular & interventional radiology.2023;34(4):685-693.Doi:10.1016/j.Jvir.2022.12.028.Medtronic literature review found a report of death and aneurysm recurrence in association with axium coils and solitaire stents.The purpose of this article was to assess changes in modified raymond¿roy classification (mrrc) occlusion classes and recurrence rates over time and evaluate recurrence-free survival after coil embolization and its predictors.This study included all patients with ruptured and unruptured saccular intracranial aneurysms who were treated with endovascular coil embolization¿either simple coil embolization or stent-assisted coil embolization¿between january 2007 and december 2016 at a tertiary hospital.Among 821 patients with an intradural intracranial saccular aneurysm, 283 patients underwent coil embolization or stent assisted coil embolization, of whom 82 were subsequently excluded from the analysis because they were lost to follow-up or had follow-up without dsa or mr angiography.Of these 82 patients, 11 patients died or were discharged without improvement, and 71 patients were discharged with improvement.Finally, 201 patients (mean age, 57.1 years; 75.5% women) with 240 aneurysms were included in the analysis.During the study period, matrix (boston scientific), axium (medtronic), or target (stryker) coils were used depending on the availability at the time.The simple coil embolization technique was used for narrow-neck aneurysms, and the stent-assisted coil embolization method using solitaire (ev3) or neuroform atla (stryker) stents was used for wide-neck aneurysms to achieve complete obliteration or densely packed aneurysms.The mrrc occlusion classes used in the study were as follows: class i, complete obliteration; class ii, residual neck; class iiia, residual aneurysm with contrast within the coil interstices; and class iiib, residual aneurysm with contrast along the aneurysm wall.The article does not state any technical issues during use of the axium coils or solitaire stents.The following intra- or post-procedural outcomes were noted: -posttreatment aneurysms were classified as mrrc class i (n = 210, 87.5%), followed by class ii (n = 14, 5.8%), class iiia (n = 10, 4.2%), and class iiib (n = 6, 2.5%).Worsening or improvements in the mrrc classes mostly happened in the first period and were generally much fewer in the later periods.For worsening, in the first period of follow-up, some of the mrrc class i closures changed to class ii (n = 30, 14.3%), class iiib (n = 15, 7.1%), or class iiia (n = 2, 1%).Only mrrc class iiia closures had an increased number of worsening in class during the second follow-up period (4, 66.7%).For improvement in class, in terms of mrrc class ii closures, 2 (14.3%) changed to class i during the first follow-up period, 2 (8%) changed to class i during the second follow-up period, and 1 (4.3%) changed to class i during the third follow-up period.In the first follow-up period, the recurrence rate was 23.3% in class i (n = 49), 21.4% in class ii (n = 3), 50% in class iiia (n = 5), and 100% in class iiib (n = 6) closures.Regression occurred in class ii closures (21.4%), class iiia closures (20%), and none of class iiib closures.In the second follow-up period, of 186 (77.5%) aneurysms that were analyzed, new recurrence occurred only in class i (n = 10, 5.8%) and class iiia (n = 1, 16.7%) closures.Regr ession occurred in 1 (14.3%) class ii closure.In the third follow-up period, of 123 (51.25%) aneurysms that were analyzed, recurrence occurred only in 1 (0.9%) class i closure.No regression of aneurysms occurred in this period.The 1- year recurrence-free survival rates among patients with aneurysms with mrrc classes i, ii, and iiia were 76.9%, 68.7%, and 42.9%, respectively; the 5-year recurrence-free survival rates were 67.1%, 68.7%, and 28.6%, respectively.-of the 54 aneurysms that were lost to follow-up during the second follow-up period, 30 had been retreated during the initial first year and 8 had not ruptured after the initial treatment.Of the 63 aneurysms that were lost to follow-up during the third follow-up period, 13 had been retreated during the second follow-up period, 28 had not ruptured after the initial treatment, and 2 had occurred in patients who had experienced ischemic strokes, which were not related to the initial treatment, and 1 aneurysm had occurred in 1 patient who had died from hemorrhagic stroke with subarachnoid hemorrhage.Of 283 patients that underwent coil embolization or stent assisted coil embolization, 82 were excluded from the analysis because they were lost to follow-up or had follow-up without dsa or mr angiography.Of these 82 patients, 11 patients died or were discharged without improvement.

Event Description

Additional information received that of the adverse events that were mentioned within the article, none of them relate directly to medtronic devices/products.

Manufacturer Narrative

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: 18170415
• MDR Text Key: 328539991
• Report Number: 2029214-2023-02237
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: 11/16/2023
• 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): Death; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female