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 Encephalopathy (1833); Loss of Vision (2139); Cerebral Edema (4403)

Event Date 02/11/2022

Event Type  Injury  

Event Description

Spiriev t, laleva l, alioski n, et al.Contrast-induced neurotoxicity presented as transient cortical blindness after stent-assisted coiling of a medium-sized unruptured basilar artery aneurysm: a case report and review of the literature.Surgical neurology international.2022;13:48.Doi:10.25259/sni_1143_2021 medtronic literature review found a report of patient complications in association with a solitaire ab and axium coil.The purpose of this article was to present a case of reversible complete cortical blindness after uneventful stent-assisted coiling of a medium-sized unruptured basilar artery aneurysm.The article does not state any technical issues during use of the solitaire ab or axium devices.The following intra- or post-procedural outcomes were noted:  - on awakening of anesthesia, the patient reported complete visual loss.Ophthalmological examination was normal.The patient was brought back to the angio-suite but there were no signs of parent vessel compromise from the endovascular implants or distal vessel occlusion.An mri of the brain was done showing no signs of brain ischemia, just mild brain edema in both occipital lobes.Given the results of the radiological studies and clinical presentation, the patient was diagnosed with contrast-induced encephalopathy.The patient continued to receive dual antiplatelet therapy as well as anticoagulation treatment with 9500 anti-xa iu/ml 0.6 ml nadroparine calcium b.I.D.; intravenous saline hydration and anti-edematous treatment ¿ dexamethasone in tapering dosage, were administered.In 72 hours, the patient had complete resolution of the visual loss and was discharged home with no additional neurological worsening.

Manufacturer Narrative

Spiriev t, laleva l, alioski n, et al.Contrast-induced neurotoxicity presented as transient cortical blindness after stent-assisted coiling of a medium-sized unruptured basilar artery aneurysm: a case report and review of the literature.Surgical neurology international.2022;13:48.Doi:10.25259/sni_1143_2021 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.

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.

Event Description

Additional information received reported there were no adverse effects associated with any of the medtronic devices.The case report concerns side effects of the contrast media used and it is a known side effect, although very rare.Therefore, the products are of excellent quality and there were no problems associated with their use.

• 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: 15890622
• MDR Text Key: 304589915
• Report Number: 2029214-2022-02023
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/16/2023
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female