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 Muscle Weakness (1967)

Event Date 07/30/2014

Event Type  Injury  

Manufacturer Narrative

Alurkar a, karanam lsp, oak s, nayak s.Endovascular treatment of fusiform a2 aneurysm with parent artery occlusion.Surgical neurology international.2014;5(suppl 4):s199-s202.Doi:10.4103/2152-7806.137752 b.3.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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

Alurkar a, karanam lsp, oak s, nayak s.Endovascular treatment of fusiform a2 aneurysm with parent artery occlusion.Surgical neurology international.2014;5(suppl 4):s199-s202.Doi:10.4103/2152-7806.137752 medtronic literature review found a report of patient complications in association with 5 axium coils and an echelon 10 microcatheter.The purpose of this article was to present a case of endovascular parent artery occlusion treatment of a ruptured fusiform a2 or proximal pericallosal artery aneurysm in a 32-year-old female who presented with subarachnoid hemorrhage.Endovascular coil occlusion along with the parent artery was planned.The article does not state any technical issues during use of the axium coils or echelon 10 microcatheter.The following intra- or post-procedural outcomes were noted: -post-procedure angiogram showed complete exclusion of the aneurysm from the circulation with parent artery sacrifice and the distal aca territory was seen filling via the pial collaterals from the middle cerebral artery.On extubation, the patient developed weakness of right lower limb (power = 2/5).She was then kept on dopamine infusion to achieve mean arterial pressure (map) of >90 mm hg in order to maintain adequate cerebral blood perfusion, thus facilitating good revascularization via good pial collaterals to retain distal aca supply.Her weakness improved completely over the next 24 hours and she was discharged on the 9th postoperative day.On 1 month clinical follow-up, she did not have any complaints and her neurological examination was normal.

• 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: 16056417
• MDR Text Key: 306254678
• Report Number: 2029214-2022-02196
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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: 12/19/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Female