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

Model Number 105-5056

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Associated with mdr #: 2029214-2023-01199.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

Moreno, a., <(>&<)> gordhan, a.(2022).Tongue avm embolization with rescue of fractured microcatheter prolapse into internal carotid artery.Vascular and endovascular surgery, 15385744221098816.Https://doi.Org/10.1177/15385744221098816.Medtronic review of the literature article found a patient who had undergone partial onyx embolization of a tongue arteriovenous mal formation (avm).Despite known incomplete treatment, which had been planned for staged embolizations, the patient decided to refuse additional procedures when symptoms resolved after the initial embolization.However, 10 years later, the patient however, 10 years later, the patient presented with recurrence presenting symptoms.A follow up diagnostic catheter-based angiogram of the tongue lesion demonstrated more pronounced venous drainage that was clinically apparent along the floor of the mouth.There was no increase in the extent of the nidus.To address the symptomatic venous prominence related to the avm, repeat onyx embolization was performed to reduce the avm flow.This repeat embolization procedure was complicated by microcatheter entrapment and fracture.It was reported that a marathon microcatheter was used to navigate to the proximal aspect of the avm nidus and onyx 18 was used for embolization.Nidal injection of onyx was fluoroscopically observed and removal of the microcatheter was based on identifying satisfactory obliteration of nidal components.The catheter was then immediately withdrawn.During removal, the catheter fracture and the fractured segment was looping into the internal carotid artery (ica).It was noted by the physicians that the catheter separation and retention was likely due to a multiple factors of onyx reflux and patient vessel tortuosity.A non-medtronic carotid stent was implanted across the carotid bifurcation to jail the distal catheter fragment against the vessel wall and to prevent thromboembolic risk.The patient was placed on dual antiplatelet medication for 60 days post procedure.At clinical follow up, 6 months later, the patient indicated improvement in her speech and stabilization of her dysphagia.At this time, a carotid ultrasound has demonstrated no free-floating catheter segments in the internal carotid artery.

• 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: 17409724
• MDR Text Key: 320078353
• Report Number: 2029214-2023-01200
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• 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: 07/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/27/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female