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

Model Number UNK-NV-AXIUM

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

Bhatia v, hosur b, kumar a.Balloon-catheter buddy technique for coiling of very small aneurysm.Journal of clinical interventional radiology.2022;6(1):68-70.Doi:10.1055/s-0041-1729779 medtronic literature review found a report of patient complications in association with an axium coil and echelon-10 microcatheter.The purpose of this article was to describe a technique for controlled catheter movement and successful coiling of a very small aneurysm and present the case of a 35 year old man with a sudden-onset headache for the last 4 days.Noncontrast computed tomography (ncct) revealed modified fischer grade iii subarachnoid hemorrhage.The clinical examination revealed e4v5m6 status, world federation of neurosurgeons (wfns) grade i, and hunt and hess grade ii.They had a history of drug abuse for the past 5 years.A computed tomography (ct) angiography head was done which revealed a very small outpouching arising from left a1 anterior cerebral artery (aca).They were taken for diagnostic digital subtraction angiography (dsa) which showed the presence of a very small aneurysm of size 2.6 mm × 2.2 mm with the neck of 1.5 mm arising from proximal left a1 aca which was directed posterosuperior.There was severe vasospasm involving the anterior circulation.The patient was taken for endovascular coiling.  the following intra- or post-procedural outcomes and technical issues were noted: -the traxcess microwire and echelon-10 microcatheter were advanced into the left a2 aca.Repeated attempts to cannulate the aneurysm with gentle withdrawal of the microcatheter from distal aca or careful advancement over the wire into the sac met with failure as there was a tendency of microcatheter to fall into the left middle cerebral artery(mca).Repeat shaping of wire and microcatheter also failed to cannulate the aneurysmal sac.The controlled fine movement of the microcatheter was not possible and it was repeatedly falling into the left mca.A different technique was employed to successfully place the microcatheter at the aneurysm neck.A sceptor balloon catheter was placed into the left m1 mca over the microwire first.The microwire and microcatheter were then advanced into the left a2 aca.The proximity of the microcatheter and balloon catheter as buddy allowed the natural friction resulting in controlled movement of the coiling microcatheter and it was successfully placed near the neck of the aneurysm.The buddy technique allowed for stable positioning of the coiling microcatheter and a 2 mm × 2 mm axium prime extra soft coil was successfully placed.Complete nonopacification of the aneurysm was achieved and the coil was detached after 10 minutes.However, during microcatheter retrieval, a small coil loop migrated into the left a1 aca.After two days, the patient developed right hemiparesis with grade iii power.There was severe vasospasm in the left mca/aca territory for which intra-arterial nimodipine was given.The patient started on intravenous (iv) mildrone for the next 48 hours which resulted in some improvement in power.No infarcts were seen on the ncct head.The patient was discharged after 1 week with mild residual right hemiparesis.

Manufacturer Narrative

Bhatia v, hosur b, kumar a.Balloon-catheter buddy technique for coiling of very small aneurysm.Journal of clinical interventional radiology.2022;6(1):68-70.Doi:10.1055/s-0041-1729779 see manufacturer report # 2029214-2022-02069 for another event from this article.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: 15929334
• MDR Text Key: 308017166
• Report Number: 2029214-2022-02070
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/23/2022
• Initial Date FDA Received: 12/06/2022
• 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 Age: 35 YR
• Patient Sex: Male