MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number QC-6-15-3D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Foreign Body Reaction (1868); Headache (1880); Dysphasia (2195); Cerebral Edema (4403); Paresthesia (4421); Hallucination (4428)

Event Date 01/07/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: bakola, e., papagiannopoulou, g., palaiodimou, l., lagios, k., archontakis, e., theodorou, a., katsanos, a.H., triantafyllou, s., zouvelou, v., lachanis, s., tzanetakos, d., tzartos, j.S., giannopou.Delayed leucoencephalopathy as a complication after endovascular therapy of intracranial aneurysms¿ a case series.Journal of clinical medicine 2 2023.Doi:10.3390/jcm12020496 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 #2029214-2023-02385 and 2029214-2023-02387 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.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

Bakola e, papagiannopoulou g, palaiodimou l, et al.Delayed leucoencephalopathy as a complication after endovascular therapy of intr acranial aneurysms¿a case series.Journal of clinical medicine.2023;12(2):496.Doi:10.3390/jcm12020496 medtronic literature review found a report of patient complications in association with axium coils and a marksman and rebar catheter.The purpose of this article was to describe three consecutive cases presenting at the researcher's tertiary care stroke center with delayed non ischemic cerebral enhancing (nice) lesions after endovascular treatment (evt) of cerebral aneurysms during the last three years, and to discuss the relevant literature, the clinical and imaging characteristics as well as potential treatment strategies.The following intra- or post-procedural outcomes were noted: a 64-year-old woman presented to the emergency department with subacute-onset headache, auditory hallucinations, paresthesias and we akness of the left upper limb with an initial national institutes of health stroke scale (nihss) score of 3 points.Her past medical history included non-traumatic subarachnoid hemorrhage (sah) one year ago, due to aneurysm rupture of the right posterior communicating artery (pcom), which was uneventfully treated with endovascular coil embolization (helix qc-2-4-3d, qc-3-4, qc-6- 15-3d; microcatheter marksmann fa-55150-1030).  computed tomography (ct) of the brain revealed right temporoparietal hypodense lesions.Magnetic resonance imaging (mri) of the brain confirmed right temporoparietal subcortical lesions, surrounded by vasogenic edema without diffusion restriction.Additionally, susceptibility-weighted imaging (swi) showed low-signal spots within the lesions, suggesting deposition of paramagnetic material and slight gadolinium enhancement in the post-gadolinium t1-weighted sequences.Extensive work-up for infectious, paraneoplastic and autoimmune causes was negative.Based on the recent history of evt and the mr characteristics of the lesions, the diagnosis of delayed immune-mediated encephalopathy was highly considered.Steroid pulse therapy (1000 mg of methylprednisolone iv/day for 5 days) was initiated with immediate clinical improvement (nihss score 0).Follow-up mri of the brain at 30 days demonstrated significant resolution of the white matter lesions.Two years after a slow attempt in tapering steroid treatment, the patient presented with a clinical relapse with headache, dysarthria and left upper arm weakness (nihss score 2).Brain mri also revealed a radiological relapse with enhancing lesions and low-signal spots on swi along with extensive vasogenic edema, and a second steroid pulse treatment was initiated resulting in clinical and radiological recession.A 49-year-old woman was referred to the neurologic department due to gait disorders, right-sided hemiparesis, partial seizures of the right upper limb and mild cognitive and concentration difficulties, gradually deteriorating over the last 6 months (nihss score 4).A remarkable piece of information from her medical history was the application of a flow diverter stent (p 64-mw-hpc-450-15 fd) in a non-ruptured aneurysm of the supraclinoid segment of left internal cerebral artery (ica) one year ago.The microcatheter that was used, had a hydrophilic coat (rebar 18 105-5081-153).The patient was admitted to another hospital 5 months ago and brain mri revealed multiple white-mater lesions in the left frontoparietal region with parenchymal enhancement as well as leptomeningeal enhancement after intravenous contrast administration.A thorough diagnostic work-up including csf analysis was negative.The patient underwent brain biopsy.The neuropathological findings were consistent with chronic necrotizing granulomatous inflammation, yet without any infectious or malignant source.Based on the previous findings, encephalopathy associated with immune reaction against coiling was a plausible diagnosis and the patient was treated with steroid pulse therapy continued by per os steroids with significant symptomatic recession (nihss score 1).A follow-up mri brain one month later confirmed a significant reduction of white-matter lesions.Tapering of corticosteroids resulted in clinical and neuroimaging recurrence of the immune-mediated leukoencephalopathy six months later with an nihss score of two that was treated with steroid pulse therapy.

• Brand Name: AXIUM 3D
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING 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: 18339095
• MDR Text Key: 330665414
• Report Number: 2029214-2023-02388
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K081465
• 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
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: QC-6-15-3D
• Device Catalogue Number: QC-6-15-3D
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female