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

Model Number UNK-NV-MARATHON

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

Patient Problem Perforation (2001)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Gargula s, saint-maurice j-p, labeyrie m-a, et al.Embolization of internal carotid artery branches in juvenile nasopharyngeal angio fibroma.The laryngoscope.2021;131(3):e775-e780.Doi:10.1002/lary.29119.Medtronic literature review found a report of patient complications in association with the marathon microcatheter.The purpose of this article was to report on the feasibility and clinical impact of superselective embolization of internal carotid artery (ica) branches in complex cases of juvenile nasopharyngeal angiofibroma (jna).This was a single-center retrospective study of all patients operated on for jna between 2000 and 2018.The patients treated with embolization of branches of the ica were identified.100 patients were operatedon for jna in the study center.Eight patients with missing data were excluded.Ninety-two patients were included.Embolization of branches of the ica was attempted in 14 cases of advanced or recurrent tumors and was ultimately possible in nine cases.All patients underwent arterial angiography under general anesthesia.The procedure began with catheterization of the right femoral artery, progressing slowly to the common carotid artery with a 6 french caliber catheter.Selective arteriography of the vascular region of the ica and eca was then performed.Superselective catheter embolization of branches of the eca was performed first.Embolization of branches of the ica was then attempted in selected patients if the neuroradiologist considered that there was significant input from one or several branches of the ica on the angiogram.A marathon microcatheter (medtronic, minneapolis, mn) was inserted in the target vessel with a 0.08 or 0.07 hybrid guidewire, and single point incremental forming platinum flow coils (balt, montmorency, france) were introduced to block the vascular lumen.Of note, embolization could not be performed in some patients either because the feeding vessels were too short or small or because the angle between the ica and its branch was too acute, making it difficult to catheterize the target vessel.Embolization of branches of the ica was performed in all patients by the same senior neuroradiologist.Preoperative angiography with embolization was performed in 89 patients.Feeding vessels originating from the ica were found in 68 patients (76%).Embolization of ica branches was not considered until 2004.Among the 65 patients operated on between 2004 and 2018, embolization of ica branches was attempted in 14 patients, but it was possible only in nine patients (64.3%) due to the small size or the course of the branches in the five remaining patients.In eight patients, embolization was performed only on branches from 1 ica, and in one patient branches from both icas were occluded.There were no immediate or delayed complications after the embolization of ica branches.To assess the impact of this strategy, these nine patients (ica embolization group) were then matched to a control group of nine comparable patients.The article does not state any technical issues during use of the marathon catheter.The following intra- or post-procedural outcomes were noted: -there were no complications after embolization.The mean intraoperative blood loss was 1428 ml in the ica embolization group versus 1355 ml in the control group.One patient with intraoperative cerebrospinal fluid leak (csf) leakage in the ica embolization group was treated immediately, with no postoperative recurrence.Residual disease was found in three patients (33%) in the ica embolization group and in four patients (44%) in the control group, with a mean follow-up of 21 and 30 months, respectively.

Manufacturer Narrative

Gargula s, saint-maurice j-p, labeyrie m-a, et al.Embolization of internal carotid artery branches in juvenile nasopharyngeal angio fibroma.The laryngoscope.2021;131(3):e775-e780.Doi:10.1002/lary.29119 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.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.G2: the country of the event is fr.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.

• Brand Name: MARATHON
• 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: 17330406
• MDR Text Key: 319098760
• Report Number: 2029214-2023-01116
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093750
• 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: 07/14/2023

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-MARATHON
• Device Catalogue Number: UNK-NV-MARATHON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/14/2023
• 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 Age: 16 YR