MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARKSMAN

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

Patient Problems Muscle Weakness (1967); Thromboembolism (2654)

Event Date 02/15/2022

Event Type  Injury  

Event Description

Pabst lm, zyck sa, youssef p.Successful thrombectomy in a pediatric patient with large vessel occlusion and covid-19 related multisystem inflammatory syndrome.Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.2023;29(2):214-216.Doi:10.1177/15910199221080873 medtronic literature review found a report of clot migration in association with the solitaire stent and marksman microcatheter.The purpose of this article was to report the first known case of a child with multisystem inflammatory syndrome in children (mis-c) complicated by an acute ischemic stroke with right m1 occlusion and large penumbra who underwent thrombectomy with tici 3 recanalization.It was reported that a previously healthy school-age child was admitted to the pediatric intensive care unit (picu) with mis-c requiring vasoactive and respiratory support.Presenting symptoms included fever, abdominal pain, sore throat, myalgias, emesis and conjunctival injection with laboratory evidence of multi-organ dysfunction.On the third day after admission, the child developed left hemiplegia, left facial droop, homonymous hemianopsia and dysarthria with a pediatric nih stroke scale (pednihss) of  16.Imaging found an acute right lenticulostriate infarct and occlusion of the right m1 segment of the middle cerebral artery.Under general anesthesia, right femoral access was obtained.A 6 french arrow-flex 65-centimeter sheath (teleflex) was placed.The right internal carotid artery was selectively catheterized with a 5 french angled glide catheter over a 0.035 inch glidewire (terumo).The shuttle was advanced over the select catheter to the distal cervical right internal carotid artery.Right internal carotid artery angiography was p erformed, which demonstrated a right m1 occlusion.A catalyst-6 distal access catheter was advanced co-axially with a marksman 0.027 inch microcatheter and 0.014 inch wire.The microcatheter and 0.014 inch wire were used to cross the lesion and the distal access c atheter was advanced to the proximal face of the lesion.A solitaire 4 × 40 mm stent retriever was deployed across the lesion.The microcatheter was removed and the stent retriever was left open for four minutes under continuous aspiration.The stent retriever was then retrieved under continuous aspiration.Control angiography after the first pass showed proximal migration of the clot to the more proximal m1 segment.The same technique was repeated for a second pass using a solitaire 6 × 40 mm stent retriever.Control right internal carotid artery angiography was performed and demonstrated tici3 revascularization.There was no radiologic evidence of vasculitis.Follow-up imaging 48 h after thrombectomy showed stable size of the known infarction and four small areas of micro-infarction in right cortical white matter.The child was transferred to the inpatient rehabilitation ward on post stroke day seven, where he completed two weeks of intensive therapy.At time of discharge, he was walking independently and had a pednihss of 1 for mild left arm weakness.At two month follow-up in the pediatric stroke clinic, he reported a full return to school without any cognitive or physical limitations.The child continued to get weekly physical therapy for mild left-sided weakness and exam demonstrated a stable pednihss of 1 for left arm weakness.The article does not state any technical issues during use of the solitaire the following intra- or post-procedural outcomes were noted: -proximal migration of the clot -mild left arm weakness.

Manufacturer Narrative

Pabst lm, zyck sa, youssef p.Successful thrombectomy in a pediatric patient with large vessel occlusion and covid-19 related multisystem inflammatory syndrome.Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.2023;29(2):214-216.Doi:10.1177/15910199221080873 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 see related report #2029214-2023-02466.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: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 18388733
• MDR Text Key: 331308835
• Report Number: 2029214-2023-02467
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARKSMAN
• Device Catalogue Number: UNK-NV-MARKSMAN
• 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): Other
• Patient Sex: Male