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 Problems Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Unspecified Nervous System Problem (4426)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

Chen x, zhang l, zhu h, et al.Transvenous embolization of hemorrhagic brain arteriovenous malformations: case reports and literature review.Frontiers in neurology.2022;13:813207.Doi:10.3389/fneur.2022.813207.Date of event : 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.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

Chen x, zhang l, zhu h, et al.Transvenous embolization of hemorrhagic brain arteriovenous malformations: case reports and literature review.Frontiers in neurology.2022;13:813207.Doi:10.3389/fneur.2022.813207 medtronic literature review found a report of patient complications in association with the navien guiding catheter, marathon microcatheter, apollo microcatheter, echelon microcatheter, hyperglide balloon, mirage guidewire, and onyx.The purpose of this article was to report the authors preliminary experience with four patients with a hemorrhagic brain arteriovenous malformation (avm) who underwent transvenous embolization (tve) and review the relevant tve literature.Four patients that underwent tve of a hemorrhagic brain avm between july 2019 and july 2020 were retrospectively analyzed using the clinical and imaging data of these patients and those reported in previously published studies.One patient underwent tve alone and three underwent combined transarterial and transvenous approaches.The following technical issues during use of the onyx were noted: -for case 2, after the balloon was inflated to provisionally occlude the internal carotid artery, onyx was injected transvenously into the avm nidus through the microcatheter, and 2 cm of embolysate reflux was encountered prior to achieving sufficient retrograde nidal penetration.The article does not state any technical issues during use of the navien guiding catheter, marathon microcatheter, apollo microcatheter, echelon microcatheter, hyperglide balloon, or mirage guidewire, the following intra- or post-procedural outcomes were noted:" -hemorrhagic complications were commonly seen during microcatheterization or microcatheter retrieval.For case 1, no clinical complications were associated with the procedure, and the patient was discharged from the hospital with slight right limb weakness and a modified rankin scale (mrs) score of 2, which was unchanged as compared to the preoperative period.Dsa 4 months later confirmed avm obliteration.At the 4-month follow-up, the patient was asymptomatic with an mrs score of 0.For case 2, after the balloon was inflated to provisionally occlude the internal carotid artery, onyx was injected transvenously into the avm nidus through the microcatheter, and 2 cm of embolysate reflux was encountered prior to achieving sufficient retrograde nidal penetration.The final dsa showed complete obliteration of the avm.Unfortunately, the child awoke with difficulty from anesthesia, dyna ct showed avm hemorrhage.The patient then underwent craniotomy for evacuation of intracranial hematoma and nidus resection.After surgery, the patient was awake and conscious with stable vital signs (mrs score, 3).One year later, dsa confirmed complete avm obliteration and mrs score was 2 for case 4, the patient underwent conventional transarterial embolization via the temporal branches of the mca using onyx 18tm.Pos tembolization dsa showed a residual nidus.Tve was performed due to the lack of optimal arterial access.A microcatheter was positioned at the origin of the venous collector, microangiography was then performed to better observe the angioarchitecture of draining veins and adjust the position of the microcatheter tip.Onyx 18tm was injected transvenously into the avm nidus through a microcatheter until anatomic obliteration of the avm.Six months later, the patient was independent with mrs score of 2 and in a good condition.Dsa confirmed complete avm obliteration.

• 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: 16301599
• MDR Text Key: 308826726
• Report Number: 2029214-2023-00180
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/03/2023

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: 02/01/2023
• Initial Date FDA Received: 02/04/2023
• 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