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 Problem Renal Failure (2041)

Event Date 09/06/2022

Event Type  Death  

Manufacturer Narrative

Yanagawa t, shibata a, tabata s, kurita e, ikeda s, ikeda t.Case of effective suction to secure the true lumen for acute occlusion after carotid endarterectomy.Radiology case reports.2022;17(11):4144-4147.Doi:10.1016/j.Radcr.2022.08.008.Please note that event date is based off of the date of online 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

Yanagawa t, shibata a, tabata s, kurita e, ikeda s, ikeda t.Case of effective suction to secure the true lumen for acute occlusion after carotid endarterectomy.Radiology case reports.2022;17(11):4144-4147.Doi:10.1016/j.Radcr.2022.08.008.Medtronic literature review found a report of patient complications in association with the marathon microcatheter.The purpose of this article was to report a case of suction-enabled advancement of the wire into the true lumen during endovascular treatment of an acute occlusion of the internal carotid artery after carotid endarterectomy.The patient underwent carotid endarterectomy (cea) at another hospital for left internal carotid artery (ica) stenosis.When the intraoperative shunt was used, the balloon on the side of the ica was moved to adjust blood flow, but the surgery was completed without any major problems.The patient exhibited no abnormal neurological manifestations immediately after the surgery, but aphasia and right-sided paralysis appeared 13 hours after the procedure.Diffusion-weighted magnetic resonance imaging showed cerebral infarction in the left hemisphere and magnetic resonance angiography showed occlusion of the left ica; for this reason, the patient was transported to the study's hospital for endovascular treatment.Before commencement of treatment, the patient received aspirin, 200 mg, and clopidogrel, 300 mg.Angiography of the left common carotid artery showed complete occlusion distal to the endarterectomy site.First, a 9-fr balloon guiding sheath was advanced into the common carotid artery proximal to the occluded site.Researchers attempted to pass a microcatheter (marksman) and a 0.014-inch micro-guidewire (asahi chikai 14) through the occluded segment, but the microguidewire could not penetrate the lesion.An aspiration catheter was then advanced (ace 68; penumbra) to the occlusion and direct aspiration was performed for 2 minutes.The aspiration catheter was removed, but no definite thrombus was noted; however, angiography showed inflow of contrast material into the vessel, which indicated distal widening; the micro-guidewire was then advanced slowly.After advancing approximately 7 cm, the wire again became stuck, and angiography revealed that the occluded segment had extended to the distal part of the vessel.It was noted that there was great difficulty in advancing the wire further distally but they were eventually able to reach the intact part of the ica.A spiderfx embolic protection device (medtronic) was deployed, and gentle percutaneous transluminal angioplasty at the site of occlusion was performed to guide the stent distally.The longest stent available (wallstent) was implanted, but stenosis remained in the distal portion of the ica.Percutaneous transluminal angioplasty was performed again, but the stenosis did not improve, and another stent was implanted (wallstent).Eventually good re-expansion of the ica was achieved and intracranial perfusion was restored.The patient¿s right-sided paralysis diminished soon after the procedure, but the aphasia remained.On magnetic resonance imaging, the ica was well delineated, but a well-defined infarction was identified in the frontal lobe.  rehabilitation was continued for the patient.However, the patient died 5 months following surgery, due to worsening chronic renal failure.The following technical issues were noted during use of the marksman: -marksman microcatheter and a 0.014-inch micro-guidewire asahi chikai 14 were attempted to pass through the occluded segment, but the micro guidewire could not penetrate the lesion.  the following intra- or post-procedural outcomes were noted: -stenosis remained in the distal portion of the ica.Percutaneous transluminal angioplasty was performed again, but the stenosis did not improve, and another stent was implanted.-the patient¿s aphasia remained.-a well-defined infarction was identified in the frontal lobe.Rehabilitation was continued for the patient.However, he died 5 months following surgery, due to worsening chronic renal failure.

• 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: 16635970
• MDR Text Key: 312217716
• Report Number: 2029214-2023-00553
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202318
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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: 03/03/2023
• 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): Death