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 Ischemia (1942); Ischemia Stroke (4418)

Event Date 04/29/2022

Event Type  Injury  

Event Description

Mizutani, k., akiyama, t., tomita, h., toda, m.Role of endovascular treatment for ruptured aneurysms involving the anterior spinal artery at the craniocervical junction.Journal of neuroradiology.2023.Vol.50 (1), pp.44-49.Doi: 10.1016/j.Neurad.2022.04.003 summary: ruptured aneurysms at the craniocervical junction (ccj) involving the anterior spinal artery (asa) are rare and consist of heterogenous lesions with variable clinical entities.However, the standard therapeutic strategy for the lesions has not been well- established.Moreover, despite advances in modern neurointervention, reports describing endovascular treatment for this specific lesion have been few.Here, we report three cases of ruptured aneurysms on the pial tributary of the asa at the ccj, which were subsequently treated by transarterial glue injection or coil embolization.Endovascular treatment can be a therapeutic option, particularly for these ruptured aneurysms.Either transarterial glue injection or coil embolization can be effective depending on the type of etiology and the surrounding vasculature anatomy.Reported event: case 1 - a 42-year-old man without previous medical history presented with cervical pain and diplopia at a nearby hospital.A head computed tomography (ct) scan revealed a diffuse sah from the ccj to the suprasellar cistern.A ruptured aneurysm on a tributary of the asa was identified in the digital subtraction angiography (dsa).Six years after the initial embolization, a tiny new aneurysm was formed precisely proximal to the previous one.A marathon microcatheter was navigated to the asa and its tributary using a chikai 08 guidewire, although the microcatheter did not reach the aneurysm this time.Subsequently, the vessel proximal to the aneurysm was embolized with four i-ed coils silkysoft type.The blood flow inside the aneurysm was stagnated, and the left pica lost the blood supply from the embolized collateral.The post-operative magnetic resonance (mr) imaging revealed multiple small cerebellar infarctions but was discharged without any neurological deficit.The mr scan six months after the second embolization (fig.1k) did not indicate any aneurysm recurrence.See attached literature article no specific device information provided.

Manufacturer Narrative

B3: the event date noted was the date of the publication as the date of the event was unknown.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.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: 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: 18711801
• MDR Text Key: 335528027
• Report Number: 2029214-2024-00293
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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
• Date Manufacturer Received: 02/08/2024
• 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): Life Threatening
• Patient Age: 42 YR
• Patient Sex: Male