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 Aneurysm (1708); Headache (1880); Hematoma (1884)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: suleyman, k., korkmazer, b., kocer, n., islak, c., & kizilkilic, o.Evaluation of short- and long-term results of y-stent-assisted coiling with leo stents in endovascular treatment of wide-necked intracranial bifurcation aneurysms.Neuroradiology: a journal dedicated to neuroimaging and inte 4 2023.Doi:10.1007/s00234-023-03116-x 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 reports #2029214-2023-01910 and #2029214-2023-01911.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

Suleyman k, korkmazer b, kocer n, islak c, kizilkilic o.Evaluation of short- and long-term results of y-stent-assisted coiling with leo stents in endovascular treatment of wide-necked intracranial bifurcation aneurysms.Neuroradiology: a journal dedicated to neuroimaging and interventional neuroradiology.2023;65(4):785-791.Doi:10.1007/s00234-023-03116-x.Medtronic literature review found a report of patient complications in association with the axium prime coil and echelon catheter.The purpose of this article was to  evaluate the feasibility, safety, and efficacy of y-stent-assisted coiling (y-sac) using leo baby® stents in treating of bifurcation aneurysms.Patients who underwent y-sac using a braided stent (leo baby®, montmorency, france) for wide-necked intracranial aneurysms between august 2009 and june 2019 and whose radiological and clinical follow-up data for at least 6 months could be obtained were evaluated.Data were obtained from patient records and analyzed retrospectively.Wide-necked bifurcation aneurysms were detected in 265 patients during the study.Subsequently, non-y-sac treatment was performed on 89 of these patients.After diagnosis, 15 patients did not reapply to our unit.Y-sac was applied to 161 of the patients, with 111 using leo baby, 30 using lvis jr, and 20 using neuroform atlas stents.The mean age of these 111 patients was 56.0 years (range, 25¿88 years).Of these, 74 (66.7%) were female and 37 (33.3%) were male.Endovascular intervention was performed under general anesthesia by using the unilateral femoral approach.Heparin was used as an an ticoagulant during the procedure.Nimodipine 0.05 mg/ml was used to prevent possible vasospasm.After the placement of 6f guiding sheath (neuron max 088; penumbra) in the femoral artery, the target artery was accessed with a 6f guiding catheter (envoy; codman <(>&<)> shurtleff).After obtaining the appropriate study projection for the target aneurysm, a microcatheter (echelon 10, covidien; vasco10, balt extrusion) was inserted into the daughter branch originating from the aneurysm neck with a sharper angle.Another microcatheter (echelon 10; headway 17, microvention) was placed in the aneurysm sac for coiling.The first daughter branch of the parent artery was catheterized, followed by the selection and placement of an appropriately sized leo baby stent.Subsequently, the second daughter branch was catheterized through the first stent.Then, the second leo baby stent was placed in the second   daughter branch to form a y-stent configuration by passing through the first stent placed in the parent artery.After both stents were successfully placed, platinum-only material (target detachable coils, stryker neurovascular, kalamazoo, michigan; microplex/ cosmos/hypersoft 3d, microvention; axium, covidien) was used for coiling.Coiling was considered complete when the aneurysm sac was completely occluded, no angiographic filling was observed, or another coil could not be placed safely.The article does not state any technical issues during use of the axium coils or echelon catheter.The following intra- or post-procedural outcomes were noted: -the overall complication rate was 4.8%, and one patient died during the post-procedural follow-up.Procedure-related inguinal hematoma developed in five (4.5%) patients, in which one patient died because of stent occlusion on the fifth day after anticoagulant treatment discontinuation due to hematoma.The primary mortality rate was 0.9%.In-stent thrombus was not detected in any patient except for the patient who died after the procedure.No patient had bleeding due to anticoagulant therapy.-headache persisted in two patients despite successful intervention.-immediate aneurysm occlusion rates were determined as modified raymond-roy classification (mrrc) i 95.5% (n=106), mrrc ii 3.6% (n=4), mrrc iiia 0.9% (n=1).In the sixth month, aneurysm occlusion rates were found to be complete and nearly complete in all patients (mrrc i 94.6%, n=105 and mrrc ii 4.5%; n=5, respectively).Long-term follow-up data of 91 patients were obtained.Of these, 96.7% (n=88) were mrrc i and 3.3% (n=3) were mrrc ii.-during the follow-up period, three (2.7%) patients had worsening in their mrrc, of whom only one  patient was retreated endovascularly with coiling 12 months after y-sac procedure.

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.

Event Description

Additional information was received that none of the adverse events were related to medtronic devices.

• 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: 17852779
• MDR Text Key: 324710619
• Report Number: 2029214-2023-01912
• 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,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• 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: 12/05/2023
• 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: 56 YR
• Patient Sex: Female